Product Code: FRN FDA class 2 21 CFR 880.5725

Pump, Infusion

General Hospital

An infusion pump is a device used to deliver controlled volumes of fluids, medications, or nutrients directly into a patient's circulatory system over a defined period of time. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification before marketing. The product code is FRN, regulated under 21 CFR 880.5725, within the General Hospital medical specialty. No special flags apply to this device.

View on FDA

510(k)s

848

FEI Numbers

149

Registration Numbers

149

Unique Applicants

268

Years Active

Basic Information

Product Code: FRN
Device Class: FDA class 2
Regulation Number: 880.5725
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 848 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252015	FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing	Jan 28, 2026	Substantially Equivalent	Koru Medical Systems, Inc.
K251640	SIGMA Spectrum Infusion Pump with Master Drug Library	Jul 28, 2025	Substantially Equivalent	Baxter Healthcare Corporation
K251636	Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)	Jul 28, 2025	Substantially Equivalent	Baxter Healthcare Corporation
K242752	MRidium 3870 MRI Infusion Pump System (3870)	May 28, 2025	Substantially Equivalent	Iradimed Corporation
K243855	BD Alaris Infusion System with Guardrails Suite MX	Apr 25, 2025	Substantially Equivalent	Carefusion 303, Inc.
K242115	Plum Duo Precision IV Pump	Apr 02, 2025	Substantially Equivalent	Icu Medical, Inc.
K242114	Plum Solo Precision IV Pump	Apr 02, 2025	Substantially Equivalent	Icu Medical, Inc.
K250357	RemunityPRO Pump for Remodulin® (treprostinil) Injection	Mar 11, 2025	Substantially Equivalent	Deka Research & Development Corp.
K241736	Remunity 2.0 Pump for Remodulin (treprostinil) Injection	Jan 16, 2025	Substantially Equivalent	Deka Research and Development Corp.
K242735	Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min)	Dec 23, 2024	Substantially Equivalent	Belmont Medical Technologies
K242660	Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets	Oct 03, 2024	Substantially Equivalent	Zevex, Inc.
K242390	Novum IQ Syringe Pump (40800BAXUS)	Sep 05, 2024	Substantially Equivalent	Baxter Healthcare Corporation
K232793	Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets	May 17, 2024	Substantially Equivalent	Zevex, Inc.
K211122	Novum IQ Large Volume Pump	Mar 29, 2024	Substantially Equivalent	Baxter Healthcare Corporation
K231918	Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter	Nov 03, 2023	Substantially Equivalent	Koru Medical Systems
K230083	SAFIRA	Oct 31, 2023	Substantially Equivalent	Medovate Limited
K223607	Plum Duo Infusion System	Aug 24, 2023	Substantially Equivalent	Icu Medical, Inc.
K211218	BD Alaris System with Guardrails Suite MX v12.1.2	Jul 21, 2023	Substantially Equivalent	Carefusion 303, Inc.
K230041	Spectrum IQ Infusion System with Dose IQ Safety Software	Mar 31, 2023	Substantially Equivalent	Baxter Healthcare Corporation
K230022	Baxter SIGMA Spectrum Infusion Pump with Master Drug Library	Mar 31, 2023	Substantially Equivalent	Baxter Healthcare Corporation
K213744	Avoset Infusion Pump System	Mar 10, 2023	Substantially Equivalent	Eitan Medical , Ltd.
K222048	Spectrum IQ Infusion System with Dose IQ Safety Software	Sep 06, 2022	Substantially Equivalent	Baxter Healthcare Corporation
K211125	Novum IQ Syringe Pump	Aug 30, 2022	Substantially Equivalent	Baxter Healthcare Corporation
K220417	Spectrum IQ Infusion System with Dose IQ Safety Software	Apr 29, 2022	Substantially Equivalent	Baxter Healthcare Corporation
K214045	FreedomEdge Syringe Infusion System	Apr 29, 2022	Substantially Equivalent	Repro-Medical System, Inc., Dba Koru Medical Systems
K210074	Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable	Mar 01, 2022	Substantially Equivalent	Fresenius Kabi AG
K210073	Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo	Mar 01, 2022	Substantially Equivalent	Fresenius Kabi AG
K200176	FREEDOM Integrated Syringe Infusion System	Dec 15, 2021	Substantially Equivalent	Repro-Med Systems, Inc. Dba Koru Medical Systems
K211206	FreedomEdge(R) Syringe Infusion System	Nov 09, 2021	Substantially Equivalent	Repro-Medical System, Inc., Dba Koru Medical Systems
K192860	Sapphire Infusion Pump, Sapphire administration sets	Nov 19, 2020	Substantially Equivalent	Q Core Medical , Ltd.
K183311	Ivenix Infusion System (IIS)	Jun 07, 2019	Substantially Equivalent	Ivenix, Inc.
K190182	Unity Subcutaneous Delivery System for Remodulin	May 06, 2019	Substantially Equivalent	DEKA Research & Development
K172653	Power Infuser	Jul 18, 2018	Substantially Equivalent	ZOLL Medical Corporation
K172831	Perfusor® Space Syringe Infusion Pump System	Jun 12, 2018	Substantially Equivalent	B.Braun Medical, Inc.
K173084	Spectrum IQ Infusion System, Dose IQ Safety Software	May 11, 2018	Substantially Equivalent	Baxter Healthcare Corporation
K162613	Integrated Catch-up Freedom Syringe Driver Infusion System	Aug 31, 2017	Substantially Equivalent	Repro-Med Systems, Inc. Dba Rms Medical Products
K161469	Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module	Mar 28, 2017	Substantially Equivalent	Hospira, Inc.
K161667	Sapphire Infusion Pump	Mar 27, 2017	Substantially Equivalent	Q Core Medical , Ltd.
K143369	MRidium 3860+ MRI infusion Pump/ Monitoring System	Dec 15, 2016	Substantially Equivalent	Iradimed Corporation
K153599	Concert Medical Hands-Free Syringe (HFS)	Sep 01, 2016	Substantially Equivalent	Concert Medical, LLC
K153193	Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)	Aug 30, 2016	Substantially Equivalent	Zyno Medical, LLC
K151255	Navigator Aesthetic Delivery System	Dec 30, 2015	Substantially Equivalent	Carticept Medical, Inc.
K142596	Infusomat Space Volumetric Infusion Pump	Jun 18, 2015	Substantially Equivalent	B.Braun Medical, Inc.
K141789	PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE	Jan 16, 2015	Substantially Equivalent	Hospira, Inc.
K141389	SAPPHIRE INFUSION PUMP	Dec 11, 2014	Substantially Equivalent	Q Core Medical , Ltd.
K140783	HALO AMBULATORY INFUSION SYSTEM	Oct 17, 2014	Substantially Equivalent	Zyno Medical, LLC
K133532	ALARIS SYSTEM WITH GUARDRAILS SUITE MX	Aug 21, 2014	Substantially Equivalent	Carefusion 303, Inc.
K141654	THE BELMONT RAPID INFUSER	Jul 18, 2014	Substantially Equivalent	Belmont Instrument Corporation
K141102	HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE	Jul 08, 2014	Substantially Equivalent	Hospira, Inc.
K133801	BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY	May 07, 2014	Substantially Equivalent	Baxter Healthcare Corporation
K123049	SAPPHIRE INFUSION PUMP	Oct 17, 2013	Substantially Equivalent	Q Core Medical , Ltd.
K123822	KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET	Sep 27, 2013	Substantially Equivalent	Hk Surgical, Inc.
K130690	Z-800 INFUSION SYSTEM	Jun 12, 2013	Substantially Equivalent	Zyno Medical, LLC
K121613	AGILIA INFUSION SYSTEM	May 01, 2013	Substantially Equivalent	Fresenius Kabi AG
K124053	NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)	Mar 13, 2013	Substantially Equivalent	Carticept Medical, Inc.
K111275	CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE	Feb 01, 2013	Substantially Equivalent	Smiths Medical Asd, Inc.
K122215	NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)	Oct 26, 2012	Substantially Equivalent	Carticept Medical, Inc.
K120830	NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)	Apr 16, 2012	Substantially Equivalent	Carticept Medical, Inc.
K110535	ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION	Mar 26, 2012	Substantially Equivalent	Carefusion 303, Inc.
K110901	SYMBIQ INFUSION AND ADMINSTRATION SET	Mar 05, 2012	Substantially Equivalent	Hospira, Inc.
K112067	NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)	Sep 16, 2011	Substantially Equivalent	Carticept Medical, Inc.
K111386	MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)	Aug 29, 2011	Substantially Equivalent	Smiths Medical MD, Inc.
K101194	NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010	Jul 11, 2011	Substantially Equivalent	Carticept Medical, Inc.
K100705	ZYNO Z-800 INFUSION SYSTEM MODEL Z-800	Jul 08, 2010	Substantially Equivalent	Zyno Medical, LLC
K100798	MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C	Jun 23, 2010	Substantially Equivalent	Medrad, Inc.
K100704	ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE	May 14, 2010	Substantially Equivalent	Disetronic Medical Systems AG
K093332	DELPHI INFUSION PUMP/ DELPHI ADMINISTRATION SET MODEL IV-01000/ MODEL IV-02XXXX (WHERE X IS ANY NUMBER BETWEEN 0-9)	Dec 09, 2009	Substantially Equivalent	Delphi Medical Systems
K091441	SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET	Oct 30, 2009	Substantially Equivalent	Synergetics, Inc.
K091386	MICROFUSE DUAL RATE INFUSER	Oct 02, 2009	Substantially Equivalent	Numia Medical Technology, LLC
K091308	ALARIS PC UNIT, MODELS 8000 AND 8015	Jul 09, 2009	Substantially Equivalent	Cardinal Health 303,Inc.
K091855	THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000	Jul 01, 2009	Substantially Equivalent	Belmont Instrument Corp.
K083689	INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM	Jul 01, 2009	Substantially Equivalent	B.Braun Medical, Inc.
K090736	POWER INFUSER, MODEL M100B-3A	May 20, 2009	Substantially Equivalent	ZOLL Medical Corporation
K091042	CRONO S-PID 50	May 12, 2009	Substantially Equivalent	Cane S.R.L.
K090087	MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM	Apr 07, 2009	Substantially Equivalent	Iradimed Corporation
K081412	PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE	Dec 17, 2008	Substantially Equivalent	Hospira, Inc.
K072603	ABC SYRINGE INFUSION PUMP, MODEL 4100	Oct 23, 2008	Substantially Equivalent	Elixir Corporation
K083019	GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOFTWARE	Oct 22, 2008	Substantially Equivalent	Hospira, Inc.
K082182	AP 34 MULTI-THERAPY INFUSION PUMP	Aug 15, 2008	Substantially Equivalent	Q-Core, Ltd.
K080297	MEDRAD INTEGO PET INFUSION SYSTEM	Jun 17, 2008	Substantially Equivalent	Medrad, Inc.
K073051	MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY	May 30, 2008	Substantially Equivalent	Medrad, Inc.
K080954	T34L SYRINGE DRIVER	May 16, 2008	Substantially Equivalent	Caesarea Medical Electronics , Ltd.
K080743	LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP	Apr 25, 2008	Substantially Equivalent	Smiths Medical MD, Inc.
K072105	ALARIS SYSTEM WITH MMS, MODEL 8XXX	Dec 28, 2007	Substantially Equivalent	Cardinal Health 303,Inc.
K071588	DISPENSER DP 20	Nov 26, 2007	Substantially Equivalent	NOUVAG AG
K071545	Z-800 VOLUMETRIC INFUSION PUMP	Oct 31, 2007	Substantially Equivalent	Zyno Medical, LLC
K070235	BODYGUARD PAIN MANAGER INFUSION SYSTEM	May 18, 2007	Substantially Equivalent	Caesarea Medical Electronics , Ltd.
K070529	AFF (MARK I) VOLUMETRIC INFUSION PUMP	May 08, 2007	Substantially Equivalent	Definitive Medical Technologies, Ltd.
K070398	HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391	Apr 24, 2007	Substantially Equivalent	Hospira, Inc.
K070125	COLLEAGUE GUARDIAN CONFIGURATION TOOL; COLLEAGUE DL2 EVENT HISTORY DOWNLOAD SOFTWARE APPLICATION	Apr 16, 2007	Substantially Equivalent	Baxter Healthcare Corp
K070718	MODIFICATION TO: BODYGUARD INFUSION SYSTEM	Apr 13, 2007	Substantially Equivalent	Caesarea Medical Electronics , Ltd.
K063696	COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163	Feb 27, 2007	Substantially Equivalent	Baxterhealthcare, Inc.
K070268	SIGNATURE EDITION INFUSION SYSTEM, MODELS 710X, 720X	Feb 23, 2007	Substantially Equivalent	Cardinal Health 303,Inc.
K061108	STRYKER AUTO IRRIGATION SYSTEM	Feb 02, 2007	Substantially Equivalent	Stryker
K052973	IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K	Jan 25, 2007	Substantially Equivalent	Baxter Healthcare Corp
K062592	CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE	Nov 29, 2006	Substantially Equivalent	Smiths Medical MD, Inc.
K063288	SIGNATURE EDITION GOLD INFUSION SYSTEM, MODEL 7X3X	Nov 28, 2006	Substantially Equivalent	Cardinal Health 303,Inc.
K062700	INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM	Oct 26, 2006	Substantially Equivalent	B.Braun Medical, Inc.
K062699	PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM	Oct 26, 2006	Substantially Equivalent	B.Braun Medical, Inc.
K061325	BODYGAURD PAIN MANAGER INFUSION SYSTEM	Aug 24, 2006	Substantially Equivalent	Caesarea Medical Electronics , Ltd.
K053554	COMPUFLO	Jul 10, 2006	Substantially Equivalent	Milestone Scientific, Inc.
K061128	MODIFICATION TO MEDRAD CONTINUUM MR INFUSION SYSTEM	May 22, 2006	Substantially Equivalent	Medrad, Inc.
K060479	MODIFICATION TO BODYGUARD INFUSION PUMP SYSTEM	May 12, 2006	Substantially Equivalent	Caesarea Medical Electronics , Ltd.
K060806	HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 13088	Apr 21, 2006	Substantially Equivalent	Hospira, Inc.
K052817	EUREKA INFUSION PUMP, MODELS EUREKA-IP, EUREKA-LF	Apr 17, 2006	Substantially Equivalent	Universal Medical Technologies
K060119	MCKINLEY SATURATION CATHETER	Apr 12, 2006	Substantially Equivalent	Mckinley Medical, LLC
K052594	WILLCARE, MODEL GW-1020	Feb 10, 2006	Substantially Equivalent	Icu Medical, Inc.
K053226	ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEMS WITH FENESTRATED CATHETER AND FLOW SPLITTER	Jan 31, 2006	Substantially Equivalent	Zimmer, Inc.
K052221	AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP	Dec 08, 2005	Substantially Equivalent	Sorenson Medical, Inc.
K052218	CRONO FIVE AND CRONO PCA 50	Nov 23, 2005	Substantially Equivalent	Cane S.R.L.
K050800	NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS	Nov 23, 2005	Substantially Equivalent	Caesarea Medical Electronics , Ltd.
K051568	CADD-MS 3 AMBULATORY INFUSION PUMP	Nov 17, 2005	Substantially Equivalent	Smiths Medical MD, Inc.
K051641	ALARIS SYSTEM PC UNIT, MODEL 8001	Oct 20, 2005	Substantially Equivalent	Cardinal Health, Alaris Products
K052171	ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM WITH PATIENT CONTROL MODULE	Oct 13, 2005	Substantially Equivalent	Zimmer, Inc.
K052219	CRONO GO.	Sep 13, 2005	Substantially Equivalent	Cane S.R.L.
K052217	CRONO SUPER PID	Sep 13, 2005	Substantially Equivalent	Cane S.R.L.
K052052	HOSPIRA PLUM A+ INFUSION PUMP SYSTEM V11.5, HOSPIRA PLUM A+ 3 INFUSION PUMP SYSTEM, V11.5	Aug 24, 2005	Substantially Equivalent	Hospira, Inc.
K051045	SIMPLECHOICE 3.0 ML RESERVOIR PRO REFERENCE NUMBER RP-30	Aug 02, 2005	Substantially Equivalent	Spectrx, Inc.
K051252	MICROPUMP MP-101	May 27, 2005	Substantially Equivalent	Micrel Medical Devices S.A.
K043466	PAINPUMP2	May 10, 2005	Substantially Equivalent	Stryker Instruments
K050324	INFPUMP INFILTRATION PUMP	Apr 27, 2005	Substantially Equivalent	Carolina Medical, Inc.
K050474	VEINNOVATIONS INFILTRATION SYSTEM	Apr 14, 2005	Substantially Equivalent	Veinnovations, LLC
K050433	ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM	Apr 13, 2005	Substantially Equivalent	Zimmer Orthopaedic Surgical Products
K043204	SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP	Mar 30, 2005	Substantially Equivalent	Sgarlato Laboratories, Inc.
K043600	MEDTRONIC MICROMED 407C INFUSION PUMP, MODEL MMT-407C	Mar 29, 2005	Substantially Equivalent	Medtronic Minimed
K043590	SE INFUSION SYSTEM WITH MMS	Mar 25, 2005	Substantially Equivalent	Cardinal Health, Alaris Products
K050301	MRIDIUM 3850 MRI PUMP SYSTEM	Mar 24, 2005	Substantially Equivalent	Iradimed Corporation
K042696	BODYGUARD INFUSION PUMP SYSTEM	Mar 11, 2005	Substantially Equivalent	Caesarea Medical Electronics , Ltd.
K050107	HARVARD 2 SYRINGE PUMP, MODEL 2001-001	Feb 11, 2005	Substantially Equivalent	Harvard Clinical Technology
K042432	PHARMGUARD TOOLBOX, MODEL G6000782	Jan 04, 2005	Substantially Equivalent	Medex, Inc.
K040985	PUMP CONNECTIVITY INTERFACE	Nov 30, 2004	Substantially Equivalent	Baxter Healthcare Corp
K042980	HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, HOSPIRA GEMSTAR CONNECT SOFTWARE	Nov 17, 2004	Substantially Equivalent	Hospira, Inc.
K042228	BEELINE MOTIV, PROPOLIS, PCA	Nov 08, 2004	Substantially Equivalent	Mckinley, Inc.
K042405	PAINPUMP1; PAINPUMP2	Oct 14, 2004	Substantially Equivalent	Stryker Corp.
K042609	HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE	Oct 06, 2004	Substantially Equivalent	Hospira, Inc.
K041714	E-PAIN CARE	Oct 01, 2004	Substantially Equivalent	Breg, Inc.
K042085	CRONO F	Sep 17, 2004	Substantially Equivalent	Cane S.R.L.
K042121	SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY	Aug 26, 2004	Substantially Equivalent	Sigma Intl.
K042081	PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE	Aug 24, 2004	Substantially Equivalent	Hospira, Inc.
K041738	BAXTER INFUSOR SV (SMALL VOLUME); BAXTER INFUSOR LV (LARGE VOLUME)	Jul 09, 2004	Substantially Equivalent	Baxter Healthcare Corporation
K041414	CRONO AND CRONO, MODEL 30	Jul 08, 2004	Substantially Equivalent	Cane S.R.L.
K041241	MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600	Jul 06, 2004	Substantially Equivalent	Alaris Medical Systems, Inc.
K041550	HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE	Jun 30, 2004	Substantially Equivalent	Abbott Laboratories
K041191	COLLEAGUE VOLUMETRIC INFUSION PUMPS	Jun 25, 2004	Substantially Equivalent	Baxter Healthcare Corp
K040149	PSI-TEC PERISTALTIC INFILTRATION PUMP	Jun 03, 2004	Substantially Equivalent	Byron Medical
K041152	THINSET 1.8 ML RESERVOIR, MODEL 326A; THINSET 3.0 ML RESERVOIR, MODEL 332A	May 24, 2004	Substantially Equivalent	Applied Diabetes Research, Inc.
K040899	MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP	Apr 30, 2004	Substantially Equivalent	Medex, Inc.
K040061	MEDTRONIC MINIMED MMT-407C AMBULATORY INFUSION PUMP, MODEL MMT-407C	Apr 08, 2004	Substantially Equivalent	Medtronic Minimed
K040114	ABBOTT DATA PORT PC, MODEL 12181	Jan 29, 2004	Substantially Equivalent	Abbott Laboratories
K030739	INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE	Jan 14, 2004	Substantially Equivalent	Infusion Dynamics, Inc.
K033425	AMBIT INTERMITTENT AMBULATORY INFUSION PUMP	Nov 06, 2003	Substantially Equivalent	Sorenson Medical, Inc.
K033325	AMBIT CONTINUOUS AMBULATORY INFUSION PUMP	Nov 06, 2003	Substantially Equivalent	Sorenson Medical, Inc.
K032789	REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469	Oct 09, 2003	Substantially Equivalent	American I.V. Products, Inc.
K032771	MEDRAD CONTINUUM MR INFUSION SYSTEM	Sep 23, 2003	Substantially Equivalent	Medrad, Inc.
K032642	BEELINE SYSTEM	Sep 23, 2003	Substantially Equivalent	Mckinley, Inc.
K032005	MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332	Aug 22, 2003	Substantially Equivalent	Medtronic Minimed
K031749	BODYGUARD INFUSION SYSTEM	Aug 21, 2003	Substantially Equivalent	Caesarea Medical Electronics , Ltd.
K031600	CONDUCTION CATHETER	Aug 13, 2003	Substantially Equivalent	Micor, Inc.
K031432	KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II	Aug 07, 2003	Substantially Equivalent	Hk Surgical, Inc.
K032147	SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES	Jul 25, 2003	Substantially Equivalent	Alaris Medical Systems, Inc.
K031249	MODIFICATION TO STRYKER PAINPUMP	Jul 21, 2003	Substantially Equivalent	Stryker Instruments
K030576	ANSPACH IRRIGATION PUMP AND IRRIGATION PUMP II	May 21, 2003	Substantially Equivalent	The Anspach Effort, Inc.
K031185	ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE	Apr 30, 2003	Substantially Equivalent	Abbott Laboratories
K030885	MODIFICATION TO STRYKER PAINPUMP2	Apr 18, 2003	Substantially Equivalent	Stryker Instruments
K030459	MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS)	Apr 04, 2003	Substantially Equivalent	Alaris Medical Systems, Inc.
K030323	MRI-CADDY	Apr 02, 2003	Substantially Equivalent	Mammendorfer Institute For Physics & Medicine GmbH
K023189	VISTA BASIC WITH FM SYSTEM	Mar 20, 2003	Substantially Equivalent	B.Braun Medical, Inc.
K024190	FENESTRATED INFUSION CATHETER	Mar 17, 2003	Substantially Equivalent	Promedic, Inc.
K023083	SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800	Feb 28, 2003	Substantially Equivalent - Subject to Tracking Reg.	Mettler Electronics Corp.
K023973	AUTOMED 3200 INFUSION PUMP	Feb 27, 2003	Substantially Equivalent	Help Technologies
K023863	AUTOMED 3000 INFUSION PUMP	Feb 07, 2003	Substantially Equivalent	Help Technologies
K024056	SURESET 3.0 ML RESERVOIR, MODEL 24-103	Jan 17, 2003	Substantially Equivalent	Applied Diabetes Research, Incorporated
K024084	ABBOTT PLUM A+ INFUSION PUMP, MODEL 12391	Dec 31, 2002	Substantially Equivalent	Abbott Laboratories
K023264	MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110	Dec 19, 2002	Substantially Equivalent	Alaris Medical Systems, Inc.
K023827	PARAGON INFUSION SYSTEM WITH BOLUS	Dec 13, 2002	Substantially Equivalent	I-Flow Corp.
K023491	AUTOMED 3300 AND 3400 INFUSION PUMP SYSTEM	Dec 13, 2002	Substantially Equivalent	Help Technologies
K023062	GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT	Sep 30, 2002	Substantially Equivalent	Abbott Laboratories, Inc.
K022869	SOAKER CATHETER	Sep 20, 2002	Substantially Equivalent	I-Flow Corp.
K021988	MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM	Aug 29, 2002	Substantially Equivalent	Medrad, Inc.
K022575	PERFUSOR COMPACT WITH FM SYSTEM	Aug 21, 2002	Substantially Equivalent	B.Braun Medical, Inc.
K021350	ABBOTT PLUM A+3 MULTICHANNEL INFUSION PUMP, MODEL 12348	May 14, 2002	Substantially Equivalent	Abbott Laboratories
K013840	MICROJET CRONO PAR AND CRONO APO-GO	May 14, 2002	Substantially Equivalent	Cane S.R.L.
K013855	MICROJET CRONO H	May 09, 2002	Substantially Equivalent	Cane S.R.I.
K013776	MICROJET MODEL # CD4 AND CD4/20	Apr 26, 2002	Substantially Equivalent	Cane S.R.I.
K013234	MICROJET CRONO	Apr 26, 2002	Substantially Equivalent	Cane S.R.L.
K020947	MODIFICATION TO DYONICS INTELIJET REUSABLE CANNULAS	Apr 17, 2002	Substantially Equivalent	Smith & Nephew, Inc.
K020881	MODIFICATION TO PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT	Mar 27, 2002	Substantially Equivalent	Science Incorporated
K020251	PARAGON INFUSION SYSTEM	Feb 15, 2002	Substantially Equivalent	I-Flow Corp.
K014091	STRYKER PAINPUMP	Dec 31, 2001	Substantially Equivalent	Stryker Corp.
K013767	SIMPLICITY INFUSION RESERVOIR FOR USE TO INFUSE MEDICINE, INCLUDING INSULIN, FROM AN EXTERNAL INFUSION PUMP	Dec 12, 2001	Substantially Equivalent	Sterling Medivations, Inc.
K012383	GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT C	Oct 02, 2001	Substantially Equivalent	Alaris Medical Systems, Inc.
K011975	HORIZON OUTLOOK WITH DOSECOM	Sep 19, 2001	Substantially Equivalent	B.Braun Medical, Inc.
K012044	BI-PHASIC INFILTRATOR	Aug 28, 2001	Substantially Equivalent	Reliance Medical Corp.
K003966	WUNDCATH CONDUCTION CATHETER	Jul 17, 2001	Substantially Equivalent	Micor, Inc.
K010937	SEP-10S PLUS, AND SP-12S PRO.	Jun 25, 2001	Substantially Equivalent	Viltechmeda
K011442	ABBOTT PLUM A+INFUSION PUMP, MODEL 11971	Jun 05, 2001	Substantially Equivalent	Abbott Laboratories
K003543	STRYKER PAINPUMP PCA	Jun 05, 2001	Substantially Equivalent	Stryker Instruments
K010566	COLLEAGUE VOLUMETRIC INFUSION PUMP	May 15, 2001	Substantially Equivalent	Baxter Healthcare Corp
K011096	ABBOTT ACCLAIM ENCORE, MODEL 12237	May 01, 2001	Substantially Equivalent	Abbott Laboratories
K010924	MODIFICATION TO PLUM XL INFUSION PUMP	Apr 06, 2001	Substantially Equivalent	Abbott Laboratories
K003611	PAIN CARE MULTI-PORT CATHETER, MODEL 2000L	Dec 13, 2000	Substantially Equivalent	Breg, Inc.
K003616	COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP	Dec 12, 2000	Substantially Equivalent	Baxter Healthcare Corp
K003582	FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01	Dec 05, 2000	Substantially Equivalent	Fluidsense Corp.
K003029	INFUSOMAT P	Dec 04, 2000	Substantially Equivalent	B.Braun Medical, Inc.
K002679	6060 MULTI-THERAPY PUMP, MODEL 2M9832; 6060 EPIDURAL PUMP, MODEL 2L9351	Sep 18, 2000	Substantially Equivalent	Baxter Healthcare Corp
K002380	INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM	Sep 05, 2000	Substantially Equivalent	Baxter Healthcare Corp
K001829	MINIMED PARADIGM INSULIN PUMP, MODEL 511	Aug 18, 2000	Substantially Equivalent	Minimed, Inc.
K001828	PARADIGM 1.5ML RESERVOIR, MODEL 326	Aug 18, 2000	Substantially Equivalent	Minimed, Inc.
K993524	ADVANTIS ASC INFUSION PUMP AND ADMINISTRATION SETS	Aug 01, 2000	Substantially Equivalent	Alaris Medical Systems, Inc.
K002211	COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP 2M8151	Jul 28, 2000	Substantially Equivalent	Baxter Healthcare Corp
K002126	ABBOTT ACCLAIM ENCORE STANDARD TUBING PUMP	Jul 20, 2000	Substantially Equivalent	Abbott Laboratories
K001629	DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM	Jun 21, 2000	Substantially Equivalent	Disetronic Medical Systems AG
K000842	CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM	Jun 08, 2000	Substantially Equivalent	Sims Deltec, Inc.
K994274	QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB)	May 31, 2000	Substantially Equivalent	Quest Medical, Inc.
K000328	MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP	May 09, 2000	Substantially Equivalent	Medex, Inc.
K000821	ABBOTT GEMSTAR I.V. INFUSION PUMP - 7 THERAPY CONFIGURATION, 6 THERAPY CONFIGURATION, 1 THERAPY CONFIGURATION	Mar 24, 2000	Substantially Equivalent	Abbott Laboratories
K994375	HORIZON LIGHT	Mar 08, 2000	Substantially Equivalent	B.Braun Medical, Inc.
K994374	SOAKER CATHETER	Mar 03, 2000	Substantially Equivalent	I-Flow Corp.
K994275	SIMS PORTEX ANESTHESIA CATHETER	Feb 22, 2000	Substantially Equivalent	Sims Portex, Inc.
K991936	3.0 ML RESERVOIR, MODEL 103/193	Jan 18, 2000	Substantially Equivalent	Medtronic Minimed
K994039	ABBOTT GEMSTAR I.V. INFUSION PUMP-7 THERAPY CONFIGURATION, ABBOTT GEMSTAR I.V. INFUSION PUMP-6 THERAPY CONFIGURATION, AB	Dec 22, 1999	Substantially Equivalent	Abbott Laboratories
K993387	IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K	Nov 01, 1999	Substantially Equivalent	Baxter Healthcare Corp
K991203	IRRIGATION OR INFUSION PUMP K PUMP	Oct 15, 1999	Substantially Equivalent	Kmi Kolster Methods, Inc.
K992044	INFUSION DYNAMICS POWER INFUSER MODEL M100B	Sep 08, 1999	Substantially Equivalent	Infusion Dynamics, Inc.
K991437	WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00	Aug 30, 1999	Substantially Equivalent	Wells Johnson Co.
K992672	BELMONT FLUID MANAGEMENT SYSTEM (FMS2000)	Aug 24, 1999	Substantially Equivalent	Belmont Instrument Corp.
K991275	WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS	Jul 01, 1999	Substantially Equivalent	Mckinley, Inc.
K991013	MINIMED 407C INFUSION PUMP, MODEL 407C	Jun 23, 1999	Substantially Equivalent	Medtronic Minimed
K991501	ACCLAIM INFUSION PUMP	May 13, 1999	Substantially Equivalent	Abbott Laboratories
K991363	30 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR CONTINUOUS, PCA PUMP, PAIN MANAGEMENT, PCEA PUMP, EPIDU	May 13, 1999	Substantially Equivalent	Sorenson Medical, Inc.
K990447	1000 PRESSURE INFUSION SIGMACON 1000	May 12, 1999	Substantially Equivalent	Valley West, Inc.
K990425	SIDEKICK INFUSION KIT	Apr 23, 1999	Substantially Equivalent	I-Flow Corp.
K982640	MEDEX 3000 SERIES SYRINGE INFUSION PUMP	Apr 06, 1999	Substantially Equivalent - Subject to Tracking Reg.	Medex, Inc.
K990518	PEREGRINE WET SET, MODEL PD400.00	Mar 25, 1999	Substantially Equivalent	Peregrine Surgical , Ltd.
K990101	PAIN CONTROL INFUSION PUMP	Mar 19, 1999	Substantially Equivalent	Sgarlato Laboratories, Inc.
K980751	SABRATEK 4040 INFUSION PUMP	Feb 24, 1999	Substantially Equivalent	Sabratek Corp.
K990259	DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM	Feb 12, 1999	Substantially Equivalent	Disetronic Medical Systems
K983005	PERFUSOR COMPACT	Feb 04, 1999	Substantially Equivalent	B.Braun Medical, Inc.
K982159	ABBOTT PLUM A+ INFUSION PUMP	Jan 12, 1999	Substantially Equivalent	Abbott Laboratories
K974332	VARIABLE PRESSURE SYRINGE PUMP	Dec 29, 1998	Substantially Equivalent	Alaris Medical Systems, Inc.
K980378	MELODIE INFUSION PUMP	Dec 09, 1998	Substantially Equivalent	Compagnie DE Developpement Aguettant
K981816	CUE AMBULATORY VOLUMETRIC INFUSION PUMP	Dec 04, 1998	Substantially Equivalent	Becton Dickinson Curlin, LLC
K983975	BELMONT FLUID MANAGEMENT SYSTEM (FMS2000)	Nov 30, 1998	Substantially Equivalent	Belmont Instrument Corp.
K982170	FLUIDSENSE FLUID DELIVERY SYSTEM	Nov 30, 1998	Substantially Equivalent	Fluidsense Corp.
K983838	ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP	Nov 20, 1998	Substantially Equivalent	Abbott Laboratories
K982838	CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400	Nov 04, 1998	Substantially Equivalent	Sims Deltec, Inc.
K982836	CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM	Nov 02, 1998	Substantially Equivalent	Sims Deltec, Inc.
K983321	MICROFUSE DUAL RATE INFUSER	Oct 06, 1998	Substantially Equivalent	Baxa Corp.
K982020	METRON QA-IDS I.V. PUMP TESTER	Sep 30, 1998	Substantially Equivalent	Metron U.S., Inc.
K973593	BRIDGE SENTRY BEDSIDE UNIT, BRIDGE SENTRY ADMINISTRATION SET-STANDARD CONFIGURATION, BRIDGE SENTRY ADMINISTRATION SET 5	Aug 25, 1998	Substantially Equivalent	Bridge Medical, Inc.
K981776	ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER MC146X	Aug 03, 1998	Substantially Equivalent	Alexander Mfg. Co.
K980738	PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATION	Jun 16, 1998	Substantially Equivalent	Byron Medical
K980089	3600 PRESURE INFUSOR, SIGMACON 3600, LAPRO FLOW 3000	Mar 24, 1998	Substantially Equivalent	Valley West, Inc.
K974778	ABBOTT GEMSTAR IV INFUSION PUMP	Mar 17, 1998	Substantially Equivalent	Abbott Laboratories
K980092	SMITH & NEPHEW DYONICS INTELIJET REUSABLE CANNULAS	Mar 09, 1998	Substantially Equivalent - Subject to Tracking Reg.	Smith & Nephew, Inc.
K973917	CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSADOR PUMP COMMUNICATIONS SYSTEM	Jan 09, 1998	Substantially Equivalent	Sims Deltec, Inc.
K973851	ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M12/630	Jan 05, 1998	Substantially Equivalent	Alexander Mfg. Co.
K973609	IDA-4 AND IPT-MC	Dec 18, 1997	Substantially Equivalent - Subject to Tracking Reg.	Bio-Tek Instruments, Inc.
K972284	FLUID MANAGEMENT SYSTEM	Nov 13, 1997	Substantially Equivalent - Subject to Tracking Reg.	Belmont Instrument Corp.
K972678	MILLENNIUM CRT INFUSION PUMP AND MILLENNIUM CRT INFUSION PUMP ADMINISTRATION SETS	Oct 07, 1997	Substantially Equivalent	Mcgaw, Inc.
K973133	BIG BAG 3000 PRESSURE INFUSOR	Sep 12, 1997	Substantially Equivalent - Subject to Tracking Reg.	Byron Medical
K963574	PULSE*SPRAY INJECTOR	Jul 18, 1997	Substantially Equivalent - Subject to Tracking Reg.	AngioDynamics, Inc.
K965230	ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP	Jul 03, 1997	Substantially Equivalent	Abbott Mfg., Inc.
K961862	MODELS IDA-2 PLUS AND IPT-1	Feb 26, 1997	Substantially Equivalent - Subject to Tracking Reg.	Bio-Tek Instruments, Inc.
K961975	DISETRONIC D-MODEM	Jan 30, 1997	Substantially Equivalent - Subject to Tracking Reg.	Disetronic Medical Systems
K960512	GEMINI PC-ITX	Nov 21, 1996	Substantially Equivalent	Imed Corp.
K962709	SIGMA SYRINGE DELIVERY SYSTEM(MULTI-DOSER REV. 1/MULTI-DOSER REV. II/SINGLE-DOSER REV. 1-10/SINGLE-DOSER REV. 1-20/	Oct 07, 1996	Substantially Equivalent	Sigma Intl.
K961263	MODEL 1200 ABMULATORY INFUSION PUMP	Aug 23, 1996	Substantially Equivalent - Subject to Tracking Reg.	Patient Solutions, Inc.
K960826	CADD-PRIZM MODEL 6100 PUMP	Aug 23, 1996	Substantially Equivalent	Sims Deltec, Inc.
K955231	MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP	Jul 18, 1996	Substantially Equivalent - Subject to Tracking Reg.	Medex, Inc.
K961703	COLLEAGUE 2 VOLUMETRIC INFUSION PUMP(DUAL CHANNEL)/COLLEAGUE 3 VOLUMETRIC INFUSION PUMP(TREE CHANNEL)	Jul 08, 1996	Substantially Equivalent	Baxter Healthcare Corp
K960957	EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACK	Jun 04, 1996	Substantially Equivalent	Sims Deltec, Inc.
K955258	3030 INFUSION PUMP	Jun 03, 1996	Substantially Equivalent	Sabratek Corp.
K954826	DISETRONIC MULTIFUSE PUMP SYSTEM	May 24, 1996	Substantially Equivalent - Subject to Tracking Reg.	Disetronic Medical Systems
K955180	CADD-PCA, -MICRO, -PRIZM AMBULATORY INFUSION PUMP	May 23, 1996	Substantially Equivalent	Sims Deltec, Inc.
K953896	THE IMED AMBULATORY INFUSION PUMP, ADMINISTRATION SETS	Mar 20, 1996	Substantially Equivalent	Imed Corp.
K952967	UNIMED MEDICAL DISPENSING PUMP	Feb 09, 1996	Substantially Equivalent	A.Z.E. Medical, Inc.
K952799	ABBOTT XL3M INFUSION PUMP	Jan 18, 1996	Substantially Equivalent	Abbott Laboratories
K953098	VOLUMETRIC INFUSION PUMP	Dec 22, 1995	Substantially Equivalent	Baxter Healthcare Corp
K953731	PANCRETEC PROVIDER APM INFUSION PUMP (MODIFICATION)	Dec 13, 1995	Substantially Equivalent	Abbott Laboratories
K944352	SMARTDOSE III INFUSION CONTAINER	Nov 15, 1995	Substantially Equivalent - Subject to Tracking Reg.	River Medical, Inc.
K944351	SMARTDOSE IV PREFILLED INFUSION CONTAINER	Nov 15, 1995	Substantially Equivalent - Subject to Tracking Reg.	River Medical, Inc.
K953660	PLUM XL INFUSION PUMP (MODIFICATION)	Oct 17, 1995	Substantially Equivalent	Abbott Laboratories
K953382	ACCUPUMP 901 (MODEL NUMBERS 50 & 100)	Oct 17, 1995	Substantially Equivalent - Subject to Tracking Reg.	Pharmaceutical Infusion Technologies, Inc.
K953270	MODEL 1100 MEDMATE INFUSION PUMP	Oct 07, 1995	Substantially Equivalent - Subject to Tracking Reg.	Patient Solutions, Inc.
K943952	DISETRONIC D-MODEM	Oct 07, 1995	Substantially Equivalent - Subject to Tracking Reg.	Disetronic Medical Systems
K933825	ADI SYSTEM	Sep 19, 1995	Substantially Equivalent	Abbott Laboratories
K952794	HARVARD 2 SYRINGE PUMP	Sep 15, 1995	Substantially Equivalent	Harvard Apparatus, Inc.
K944721	9000 INFUSION PUMP	Aug 11, 1995	Substantially Equivalent - Subject to Tracking Reg.	Graseby Medical , Ltd.
K944669	FLEXIFLO QUANTUM ENTERAL PUMP	Jul 24, 1995	Substantially Equivalent	Abbott Mfg., Inc.
K945942	AUTO SYRINGE(R) AS50 INFUSION PUMP	Jul 10, 1995	Substantially Equivalent	Baxter Healthcare Corp
K950419	THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS	Jun 21, 1995	Substantially Equivalent	Imed Corp.
K944750	CORFLO 300 PUMP	Jun 19, 1995	Substantially Equivalent - Subject to Tracking & PMS	Corpak, Inc.
K944190	LIFECARE 175 INFUSER, MODIFICATION	May 23, 1995	Substantially Equivalent	Abbott Laboratories
K943692	SMART DOSE(TM)	Apr 28, 1995	Substantially Equivalent - Subject to Tracking Reg.	River Medical, Inc.
K950766	SIGMA 8000 AND SIGMA 8002	Mar 22, 1995	Substantially Equivalent	Sigma Intl. General Medical Apparatus, Inc.
K942378	POCKET PUMP	Mar 01, 1995	Substantially Equivalent	Baxa Infusion Systems
K944733	PLUM XL INFUSION PUMP	Feb 08, 1995	Substantially Equivalent	Abbott Laboratories
K941595	MICROJECT MODEL 200, MODEL 30, AND MODEL TPN-5	Dec 19, 1994	Substantially Equivalent	Microject, Inc.
K931318	3400 INFUSION PUMP	Dec 09, 1994	Substantially Equivalent - Subject to Tracking Reg.	Graseby Medical , Ltd.
K944125	ABBOTT LTE INFUSION PUMP	Dec 06, 1994	Substantially Equivalent	Abbott Laboratories
K942162	SIGMA 8000 AND SIGMA 8002	Oct 20, 1994	Substantially Equivalent	Sigma Intl.
K933545	SIEMENS FLUID DELIVERY SYSTEM, MMT-9500	Sep 29, 1994	Substantially Equivalent - Subject to Tracking Reg.	Siemens Infusions Systems
K940446	3M MODEL 3000 & MODEL 3100 INFUSION PUMP (MODIFICATION)	Aug 15, 1994	Substantially Equivalent - Subject to Tracking Reg.	Minnesota Mining and Mfg. Co.
K942161	LOCKBOX	Aug 02, 1994	Substantially Equivalent - Subject to Tracking Reg.	Pharmacia Deltec, Inc.
K941984	SABRATEK 6060 HOMERUN VOLUMETRIC INFUSION PUMP	Jul 19, 1994	Substantially Equivalent	Sabratek Corp.
K922702	PROVIDER ANNE INFUSER	Jul 13, 1994	Substantially Equivalent	Abbott Laboratories
K941151	STRATOFUSE PCA II INFUSER	Jul 07, 1994	Substantially Equivalent	Infusion Technology Intl.
K932847	CORPAK ENTERAL PUMP	Jun 17, 1994	Substantially Equivalent - Subject to Tracking Reg.	Corpak Co.
K933652	FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBING	May 18, 1994	Substantially Equivalent - Subject to Tracking Reg.	Repro-Med Systems, Inc.
K930495	PANOJECT MINIFUSOR MODEL 200 AMBU. INFUSION PUMP	Apr 26, 1994	Substantially Equivalent	Elan Medical Technologies, Ltd.
K930494	PANOJECT MINIFUSOR MODEL 100 AMBULATORY INFUSION	Apr 26, 1994	Substantially Equivalent	Elan Medical Technologies, Ltd.
K926385	BARD APII PUMP	Apr 18, 1994	Substantially Equivalent	C.R. Bard, Inc.
K940147	AUTO SYRINGE AS40A INFUSION PUMP	Apr 15, 1994	Substantially Equivalent	Baxter Corp.
K932895	RIVER PUMP	Mar 31, 1994	Substantially Equivalent	River Medical, Inc.
K931458	MEDIPAK AMBULATORY INFUSION PUMP	Mar 31, 1994	Substantially Equivalent	Medication Delivery Devices, Inc.
K924603	PHARMETRIX MINIPUMP MODEL 5120	Mar 31, 1994	Substantially Equivalent	Pharmetrix, Inc.
K924527	VIVUS 5000 INFUSION SYSTEM	Mar 29, 1994	Substantially Equivalent	I-Flow Corp.
K934671	HI-FLO INFUSION PUMP	Mar 14, 1994	Substantially Equivalent	Abbott Laboratories
K915649	BARD 500ML RESERVOIR HOLDER	Mar 07, 1994	Substantially Equivalent	C.R. Bard, Inc.
K933506	SYRINGE INFUSER	Feb 25, 1994	Substantially Equivalent	Baxa Corp.
K923224	KVOI.V. FLUSH SYSTEM	Feb 24, 1994	Substantially Equivalent	Baxter Healthcare Corp
K910007	SPRINGFUSOR 10R	Nov 02, 1993	Substantially Equivalent	Go Medical Industries Pty. , Ltd.
K923290	COMPUTER - COMPUTERS AND SOFTWARE, MEDICAL USE	Oct 27, 1993	Substantially Equivalent	A Mixed Bag Corp.
K933006	AVI INFUSION PUMPS, ADDITIONAL INTENDED USE	Oct 25, 1993	Substantially Equivalent	3M Health Care, Ltd.
K933005	AVI MODEL 600 SYRINGE PUMP	Oct 25, 1993	Substantially Equivalent	3M Health Care, Ltd.
K933144	GEMINI VOLUMETRIC INFUSION PUMP/CONTROLLER	Oct 12, 1993	Substantially Equivalent	Imed Corp.
K932544	IVAC SPACE SAVER VOLUMETRIC PUMP, MODEL 599	Oct 12, 1993	Substantially Equivalent	Y
K931549	MODEL EZ-1 SING CHAN/EZ-2 DUAL CHANNEL INFUS PUMP	Oct 12, 1993	Substantially Equivalent	Y
K922670	THE MINIMED MODEL 404-SP AND 504-S	Sep 16, 1993	Substantially Equivalent	Medtronic Minimed
K921901	PORT ACCESS INFUSION SET	Sep 10, 1993	Substantially Equivalent	Kawasumi Laboratories Co., Ltd.
K931375	ABBOTT PLUM XL INFUSION PUMP	Sep 01, 1993	Substantially Equivalent	Abbott Laboratories
K926191	SIGMA 7000 AND SIGMA70002	Aug 31, 1993	Substantially Equivalent	Sigma
K931132	CADD-MICRO(TM) MODEL 5900 AMBULATORY INFUSION PUMP	Aug 20, 1993	Substantially Equivalent	Pharmacia Deltec, Inc.
K930781	INFUSION PUMP	Aug 19, 1993	Substantially Equivalent	Y
K925311	TRILOGY INFUSION PUMP	Aug 16, 1993	Substantially Equivalent	Ivion Corp.
K930459	BARD MINI-INFUSER 1500 & 3000	Aug 10, 1993	Substantially Equivalent	Bard Medsystems Div.
K921050	ULTRAFLO RATESAVER PLUS INFUSION PUMP	Aug 03, 1993	Substantially Equivalent	Clinical Systems, Inc.
K925091	IVAC SYRING PUMP MODEL 770	Jul 08, 1993	Substantially Equivalent	Y
K925196	BARD EPIDURAL PUMP	Jun 18, 1993	Substantially Equivalent	C.R. Bard, Inc.
K925112	BIO CLINIC UNDER PATIENT SCALE	Jun 18, 1993	Substantially Equivalent	Sunrise Medical, Inc.
K924871	MODEL 880 INFUSION PUMP, MODIFICATION	Jun 18, 1993	Substantially Equivalent	3M Health Care, Ltd.
K924872	MODEL 885 INFUSION PUMP, MODIFICATION	Jun 17, 1993	Substantially Equivalent	3M Health Care, Ltd.
K924870	MODEL 480CI INFUSION PUMP, MODIFICATION	Jun 17, 1993	Substantially Equivalent	3M Health Care, Ltd.
K924869	MODEL 480CM INFUSION PUMP, MODIFICATION	Jun 17, 1993	Substantially Equivalent	3M Health Care, Ltd.
K924868	MODEL 480 INFUSION PUMP, MODIFICATION	Jun 17, 1993	Substantially Equivalent	3M Health Care, Ltd.
K924867	285CI INFUSION PUMP, MODIFICATION	Jun 17, 1993	Substantially Equivalent	3M Health Care, Ltd.
K924866	MODEL 285CM INFUSION PUMP, MODIFICATION	Jun 17, 1993	Substantially Equivalent	3M Health Care, Ltd.
K924865	MODEL 285 INFUSION PUMP, MODIFICATION	Jun 17, 1993	Substantially Equivalent	3M Health Care, Ltd.
K923875	SIDEKICK 50 PLUS AND SIDEKICK 100 PLUS	May 13, 1993	Substantially Equivalent	I-Flow Corp.
K925449	REPLACEMENT RECHARGEABLE BATTERY PACK'S	Apr 29, 1993	Substantially Equivalent	Portable Power Systems, Inc.
K923068	AVI MODEL 3100 INFUSION PUMP	Apr 20, 1993	Substantially Equivalent	3M Health Care, Ltd.
K923829	LIFECARE 175 INFUSER -- MODIFICATION	Apr 07, 1993	Substantially Equivalent	Abbott Laboratories
K922074	DCR VOLUMETRIC INFUSION PUMP W/ NEW MAINS POWER PK	Jan 22, 1993	Substantially Equivalent	Danby Medical , Ltd.
K923981	IVAC SYRINGE PUMP - 740 SERIES	Jan 15, 1993	Substantially Equivalent	Y
K923601	PANCRETEC PROVIDER INFUSION PUMP -- MODIFICAITON	Dec 23, 1992	Substantially Equivalent	Abbott Laboratories
K922909	MEDICAL BATTERY PACKS	Sep 23, 1992	Substantially Equivalent	Access / God Loves You
K914122	VITAL INFUSION PUMP	Sep 03, 1992	Substantially Equivalent	Vital Resources Corp.
K915407	PHARMETRIX MEDIPUMP MODEL 524	Sep 02, 1992	Substantially Equivalent	Pharmetrix, Inc.
K915566	DISETRONIC PANOMAT PUMP	Aug 07, 1992	Substantially Equivalent	Disetronic Medical Systems
K915646	VIVUS 50 AND VIVUS 100 PERSONAL INFUSER	Jun 15, 1992	Substantially Equivalent	I-Flow Corp.
K921378	IMED MODEL PC-4 VOLUMETRIC INFUSION PUMP/CONTROLLE	Jun 09, 1992	Substantially Equivalent	Imed Corp.
K921073	AVI MODEL 480CI INFUSION PUMP	May 26, 1992	Substantially Equivalent	3M Health Care, Ltd.
K921072	AVI MODEL 470CI INFUSION PUMP	May 26, 1992	Substantially Equivalent	3M Health Care, Ltd.
K914589	SABRATEK 3030 INFUSION PUMP	May 18, 1992	Substantially Equivalent	Sabratek Corp.
K920013	UNI-DOSE SYRINGE PUMP	May 13, 1992	Substantially Equivalent	Electrochemical Drug Delivery, Inc.
K920773	DURAFUSE INFUSION PUMP	May 08, 1992	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K920681	AVI MODEL 285CI INFUSION PUMP	Apr 06, 1992	Substantially Equivalent	3M Health Care, Ltd.
K920680	AVI MODEL 275CI INFUSION PUMP	Apr 06, 1992	Substantially Equivalent	3M Health Care, Ltd.
K920588	AVI MODEL 3000 INFUSION PUMP	Apr 06, 1992	Substantially Equivalent	3M Health Care, Ltd.
K914988	500 INFUSER	Apr 06, 1992	Substantially Equivalent	Excel Medical, Inc.
K913891	DISETRONIC(R) INFUSOR	Mar 27, 1992	Substantially Equivalent	Disetronic Medical Systems
K915499	FLO-GARD 8000 HALF-SET	Mar 06, 1992	Substantially Equivalent	Baxter Healthcare Corp
K913931	PANCRETEC PROVIDER(R) MODEL 5500 INFUS PUMP, MODIF	Mar 04, 1992	Substantially Equivalent	Abbott Laboratories
K915523	FLO-GARD(R) 6301	Feb 28, 1992	Substantially Equivalent	Baxter Healthcare Corp
K915522	FLO-GARD(R) 6201	Feb 28, 1992	Substantially Equivalent	Baxter Healthcare Corp
K912193	3000 INFUSION PUMP	Feb 14, 1992	Substantially Equivalent	Graseby Medical , Ltd.
K912192	3100 INFUSION PUMP	Feb 14, 1992	Substantially Equivalent	Graseby Medical , Ltd.
K914855	MULTIPLE DOSE CONTROLLER	Jan 24, 1992	Substantially Equivalent	Block Medical, Inc.
K914854	THUMPER	Jan 24, 1992	Substantially Equivalent	Block Medical, Inc.
K915231	EPIDURAL INDICATION FOR VOLUMETRIC INFUSION PUMPS	Jan 22, 1992	Substantially Equivalent	Q-Life Systems, Inc.
K914349	PROVIDER APM INFUSION PUMP	Dec 19, 1991	Substantially Equivalent	Abbott Laboratories
K913661	MODIFIED VOLUMETRIC INFUSION PUMP	Dec 18, 1991	Substantially Equivalent	Mcgaw, Inc.
K913907	VIVUS PS (PROGRAMMING SOFTWARE)	Dec 13, 1991	Substantially Equivalent	I-Flow Corp.
K911782	PUMPMAN(TM) AMBULATORY DRUG DELIVERY SYSTEM	Nov 22, 1991	Substantially Equivalent	Strato Medical Corp.
K911103	DANBY D.S.P. SYRINGE PUMP	Nov 08, 1991	Substantially Equivalent	Isys Medical , Ltd.
K904619	INFU.DISK	Nov 05, 1991	Substantially Equivalent	Electrochemical Drug Delivery, Inc.
K914034	INFUCARE SYRINGE PUMP TUBING SET	Oct 30, 1991	Substantially Equivalent	Infucare Products, Inc.
K913720	PANCRETEC PROVIDER ONE INFUSION SYSTEM, MODIFIED	Oct 30, 1991	Substantially Equivalent	Abbott Laboratories
K913719	PANCRETEC I.V. MODEL 5500 INFUSER	Oct 30, 1991	Substantially Equivalent	Abbott Laboratories
K913718	PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED	Oct 30, 1991	Substantially Equivalent	Abbott Laboratories
K913895	FLO-GARD(R) 6200, 6300 & 8000	Oct 21, 1991	Substantially Equivalent	Baxter Healthcare Corp
K912590	AVI MODEL 400D INFUSION PUMP	Oct 17, 1991	Substantially Equivalent	3M Avi, Inc.
K912589	AVI MODEL 840D DUAL CHANNEL INFUSION PUMP	Oct 17, 1991	Substantially Equivalent	3M Avi, Inc.
K904924	INFUSA PU SYRINGE INFUSION PUMP	Sep 10, 1991	Substantially Equivalent	Ferguson Medical
K913056	VOLUMETRIC INFUSION PUMP, MODIFICATION	Sep 06, 1991	Substantially Equivalent	Mcgaw, Inc.
K912591	AVI MICRO 210D INFUSION PUMP	Sep 06, 1991	Substantially Equivalent	3M Avi, Inc.
K904923	INFUSA T SYRINGE INFUSION PUMP	Sep 06, 1991	Substantially Equivalent	Ferguson Medical
K904925	INFUSA TS SYRINGE INFUSION PUMP	Sep 04, 1991	Substantially Equivalent	Ferguson Medical
K904922	INFUSA D.SLT SYRINGE INFUSION PUMP	Sep 04, 1991	Substantially Equivalent	Ferguson Medical
K912928	LIFECARE 4100 PCA INFUSER PLUS II	Aug 26, 1991	Substantially Equivalent	Abbott Laboratories
K912914	DANBY-DCR VOLUMETRIC INFUSION PUMP	Aug 22, 1991	Substantially Equivalent	Danby Medical , Ltd.
K912875	AVI MODEL 270CI INFUSION PUMP	Aug 20, 1991	Substantially Equivalent	3M Avi, Inc.
K912738	AVI VOLUMETRIC INFUSION PUMPS-VARIOUS MODELS	Aug 12, 1991	Substantially Equivalent	3M Avi, Inc.
K912092	MODIFIED LIFECARE MODEL 175 INFUSER	Aug 02, 1991	Substantially Equivalent	Abbott Laboratories
K911964	MODIFIED PANCRETEC PROVIDER ONE INFUSION SYSTEM	Aug 02, 1991	Substantially Equivalent	Abbott Laboratories
K905713	BARD AMBULATORY PUMP TUBING SET	Jul 15, 1991	Substantially Equivalent	C.R. Bard, Inc.
K905778	EPIDURAL INDICATION FOR BAXTER INFUSORS ATTACHMENT	Jul 12, 1991	Substantially Equivalent	Baxter Healthcare Corp
K912458	MODEL 404-SP AND 504-SP INFUSION PUMPS MODIFIED	Jun 24, 1991	Substantially Equivalent	Medtronic Minimed
K910934	FLO-GARD 6300 DUAL CHANNEL VOLUMETRIC INFUSION PUM	Jun 24, 1991	Substantially Equivalent	Baxter Healthcare Corp
K904890	BARD ALFENTANIL INFUSER	Jun 24, 1991	Substantially Equivalent	C.R. Bard, Inc.
K912031	AVI MODEL 870 DUAL CHANNEL INFUSION PUMP	Jun 18, 1991	Substantially Equivalent	3M Avi, Inc.
K911769	RATEMINDER(TM) V INFUSION PUMP, MODIFICATION	Jun 03, 1991	Substantially Equivalent	Critikon Company, LLC
K910844	INFUSION PUMP	May 31, 1991	Substantially Equivalent	Technology Transfer Intl., Inc.
K910024	VOLUMETRIC INFUSION PUMP	May 31, 1991	Substantially Equivalent	Baxter Healthcare Corp
K910758	MICREL LTD - PORTABLE INFUSION MICROPUMP-MP11	May 30, 1991	Substantially Equivalent	Technology Transfer Intl., Inc.
K910350	MICREL LTD-PORTABLE INFUSION PUMP-MP20Q	May 30, 1991	Substantially Equivalent	Technology Transfer Intl., Inc.
K911401	ABBOTT LIFECARE 5000 PUMP	May 28, 1991	Substantially Equivalent	Abbott Laboratories
K910919	ABBOTT LIFECARE 5000 PUMP MODIFIED	May 23, 1991	Substantially Equivalent	Abbott Laboratories
K911289	EPIDURAL INDICATION FOR BAXTER SYRINGE INFUS PUMP	May 21, 1991	Substantially Equivalent	Baxter Healthcare Corp
K910637	MENTOR(R) SUR-E-TROL(R)	May 13, 1991	Substantially Equivalent	Mentor O & O, Inc.
K902613	BARD PCA II PUMP WITH PROGRAM CARTRIDGES	Apr 19, 1991	Substantially Equivalent	C.R. Bard, Inc.
K910428	EPIDURAL INDICATION FOR VOLUMETRIC INFUSION PUMPS	Apr 08, 1991	Substantially Equivalent	Baxter Healthcare Corp
K910425	LARGE VOLUME ELASTOMERIC INFUSION DEVICE ATTACH.	Apr 01, 1991	Substantially Equivalent	Baxter Healthcare Corp
K910523	MODIFIED VOLUMETRIC INFUSION PUMPS ATTACHMENTS	Mar 21, 1991	Substantially Equivalent	Baxter Healthcare Corp
K910335	MTP TRANSPORT INFUSION PUMP, MODEL NO. MTPLEA	Mar 13, 1991	Substantially Equivalent	Medical Technical Products
K905696	STRATOFUSE PCA INFUSER	Mar 08, 1991	Substantially Equivalent	Strato Medical Corp.
K905611	MICRORATE PLUS INTELLIGENT PUMP	Mar 01, 1991	Substantially Equivalent	Kendall Mcgaw Laboratories, Inc.
K905610	MICRORATE INTELLIGENT PUMP	Mar 01, 1991	Substantially Equivalent	Kendall Mcgaw Laboratories, Inc.
K905251	MTP TRANSPORT INFUSION PUMP MODEL NO. 1001A	Feb 07, 1991	Substantially Equivalent	Medical Technical Products
K903571	MICREL LTD PORTABLE INFUSION MICROPUMP	Feb 01, 1991	Substantially Equivalent	Technology Transfer Intl., Inc.
K904979	AVI MODEL 600 SYRINGE PUMP, MODIFICATION	Jan 15, 1991	Substantially Equivalent	3M Avi, Inc.
K905783	MODIFIED WALKMED 400	Jan 11, 1991	Substantially Equivalent	Medfusion, Inc.
K904403	BARD AMBULATORY PCA DRUG DELIVERY SYSTEM	Dec 28, 1990	Substantially Equivalent	C.R. Bard, Inc.
K905029	MODEL 2001, MODIFICATION	Dec 24, 1990	Substantially Equivalent	Medfusion, Inc.
K903343	SYRINGE INFUSION PUMP	Nov 21, 1990	Substantially Equivalent	Baxter Healthcare Corp
K902891	VERIFUSE AMBULATORY PUMP	Nov 21, 1990	Substantially Equivalent	Block Medical, Inc.
K900217	BARD MICROBORE ANTI-SIPHON NITRO SET	Oct 31, 1990	Substantially Equivalent	C.R. Bard, Inc.
K904518	VOLUMETRIC INFUSION PUMP	Oct 17, 1990	Substantially Equivalent	Kendall Mcgaw Laboratories, Inc.
K901550	IVAC(R) SYRINGE PUMP - MODEL 770	Oct 04, 1990	Substantially Equivalent	Y
K903879	IVAC(R) SYRINGE PUMP - MODEL 740	Oct 03, 1990	Substantially Equivalent	Y
K904048	MULTI DRUG INFUSION SYSTEM	Oct 01, 1990	Substantially Equivalent	I-Flow Corp.
K901978	MULTI-DRUG INFUSION SYSTEM	Sep 28, 1990	Substantially Equivalent	I-Flow Corp.
K897086	PARKER AMBULATORY MEDICATION INFUSION PUMP 2004	Sep 28, 1990	Substantially Equivalent	Parker Hannifin Corp.
K902432	AMBULATORY INFUSER AND ASSOC. FLOW CONTROLLING SET	Sep 19, 1990	Substantially Equivalent	Abbott Laboratories
K902374	CADD-TPN MODEL 5700 AMBULATORY INFUSION SYSTEM	Sep 14, 1990	Substantially Equivalent	Pharmacia Deltec, Inc.
K903787	AVI MODEL 470CM INFUSION PUMP	Sep 05, 1990	Substantially Equivalent	3M Avi, Inc.
K903786	AVI MICRO 845 DUAL CHANNEL INFUSION PUMP	Sep 05, 1990	Substantially Equivalent	3M Avi, Inc.
K903785	AVI MODEL 400CM INFUSION PUMP	Sep 05, 1990	Substantially Equivalent	3M Avi, Inc.
K903783	AVI MICRO 275CM INFUSION PUMP	Sep 05, 1990	Substantially Equivalent	3M Avi, Inc.
K903782	AVI MODEL 270CM INFUSION PUMP	Sep 05, 1990	Substantially Equivalent	3M Avi, Inc.
K903788	AVI MICRO 285CM INFUSION PUMP	Sep 04, 1990	Substantially Equivalent	3M Avi, Inc.
K903789	AVI MICRO 885 DUAL CHANNEL INFUSION PUMP	Aug 30, 1990	Substantially Equivalent	3M Avi, Inc.
K903784	AVI MODEL 480CM INFUSION PUMP	Aug 30, 1990	Substantially Equivalent	3M Avi, Inc.
K903781	AVI MODEL 880 DUAL CHANNEL INFUSION PUMP	Aug 30, 1990	Substantially Equivalent	3M Avi, Inc.
K901755	MODEL 3001 SYRINGE INFUSION PUMP	Aug 29, 1990	Substantially Equivalent	Medfusion, Inc.
K900468	LIFECARE(R) MODEL 3 PUMP	Aug 27, 1990	Substantially Equivalent	Abbott Laboratories
K900467	LIFECARE MODEL 4 PUMP	Aug 27, 1990	Substantially Equivalent	Abbott Laboratories
K901065	INFUSION PUMP	Aug 21, 1990	Substantially Equivalent	Kendall Mcgaw Laboratories, Inc.
K896075	CADD-PCA AMBULATORY INFUSION PUMPS	Aug 21, 1990	Substantially Equivalent	Pharmacia Deltec, Inc.
K902309	PARKER MICROPUMP MODEL 2100	Aug 17, 1990	Substantially Equivalent	Chathamborough Research Group, Inc.
K902835	FTS-100 FLUID TRANSFER SYSTEM	Aug 10, 1990	Substantially Equivalent	Richard James, Inc.
K895644	CADD-PCA AMBULATORY INFUSION PUMPS	Aug 08, 1990	Substantially Equivalent	Pharmacia Deltec, Inc.
K894506	ENTERA-FLO ENTERAL FEEDING PUMP	Aug 06, 1990	Substantially Equivalent	Delmed, Inc.
K900375	BECTON DICKINSON PROGRAM 2 INFUSION PUMP	Aug 02, 1990	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K896717	PARTNER INFUSION SYSTEM:	Aug 02, 1990	Substantially Equivalent	Q-Life Systems, Inc.
K902092	RATEMINDER V INFUSION PUMP W/SECONDARY CAPABILITY	Jul 26, 1990	Substantially Equivalent	Critikon Company, LLC
K902409	BECTON DICKINSON 360 INFUSER (TM) SYSTEM	Jul 19, 1990	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K895710	ABBOTT LIFECARE 4100 PCA INFUSER	Jul 16, 1990	Substantially Equivalent	Abbott Laboratories
K895709	ABBOTT PATIENT CONTROLLED ANALGESIA (PCA) PUMP	Jul 12, 1990	Substantially Equivalent	Abbott Laboratories
K900742	RATE INFUSER PLUS	Jul 11, 1990	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K890736	TFV-2300 INFUSION PUMP	Jul 09, 1990	Substantially Equivalent	Nihon Kohden America, Inc.
K895867	PANCRETEC I.V. MODEL 5000 INFUSER	Jun 26, 1990	Substantially Equivalent	Abbott Laboratories
K893769	LIFECARE MICRO PUMP (INFUSION PUMP)	Jun 26, 1990	Substantially Equivalent	Abbott Laboratories
K895436	MODIFIED MINIMED III INFUSION PUMP	May 24, 1990	Substantially Equivalent	Medtronic Minimed
K900888	LOCKBOX	May 15, 1990	Substantially Equivalent	Pharmacia Deltec, Inc.
K896422	BURRON AMBULATORY DRUG DELIVERY SYSTEM	May 09, 1990	Substantially Equivalent	Burron Medical, Inc.
K896544	MD2 PERSONAL INFUSION SYSTEM	May 02, 1990	Substantially Equivalent	Norfolk Medical Products, Inc.
K900699	FLO-GARD 6300 BLOOD PUMPING INDICATION	Apr 10, 1990	Substantially Equivalent	Baxter Healthcare Corp
K900204	AVI MODEL 840 DUAL CHANNEL INFUSION PUMP	Apr 03, 1990	Substantially Equivalent	3M Company
K900057	LIFECARE(R) 175 INFUSER	Mar 27, 1990	Substantially Equivalent	Abbott Laboratories
K897096	MODEL 404A I.V. INFUSION PUMP ANALYZER	Mar 15, 1990	Substantially Equivalent	Dynatech/Nevada, Inc.
K897013	AVI MICRO 210CM INFUSION PUMP	Mar 08, 1990	Substantially Equivalent	3M Company
K896546	HOMEPUMP (DISP. ELASTOMERIC INFUSION DEVICE)	Feb 06, 1990	Substantially Equivalent	Block Medical, Inc.
K891289	FLO-GARD 6300 DUAL CHANNEL VOLUME INFUSION PUMP	Feb 02, 1990	Substantially Equivalent	Baxter Healthcare Corp
K896023	OHMEDA 9000 SYRINGE PUMP	Jan 04, 1990	Substantially Equivalent	Ohmeda Medical
K895797	IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICE	Jan 02, 1990	Substantially Equivalent	Imed Corp.
K896593	BECTON DICKINSON RATE INFUSER II SYSTEM	Dec 27, 1989	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K895426	AMBULATORY INFUSION PUMP	Dec 27, 1989	Substantially Equivalent	Bionica, Inc.
K894028	AMBULATORY INFUSION SYSTEM AND ACCESSORIES	Dec 22, 1989	Substantially Equivalent	Patient Solutions, Inc.
K891237	MODEL 600 SYRINGE PUMP	Dec 06, 1989	Substantially Equivalent	3M Company
K894292	BARD LIBERATOR DISPOSABLE INFUSION SYSTEM	Nov 02, 1989	Substantially Equivalent	C.R. Bard, Inc.
K893488	PULSATILE PUMP FOR GONADORELIN ACETATE	Oct 31, 1989	Substantially Equivalent	Ortho Pharmaceutical Corp.
K894321	MODEL 285 INFUSION PUMP	Oct 05, 1989	Substantially Equivalent	3M Company
K894360	MODEL 280 INFUSION PUMP	Oct 04, 1989	Substantially Equivalent	3M Company
K894320	MODEL 480 INFUSION PUMP	Oct 04, 1989	Substantially Equivalent	3M Company
K894041	PUMP-JECT SYRINGE WITH LUER-LOCK	Aug 28, 1989	Substantially Equivalent	Ziehm International, Inc.
K894037	IVAC(R) SPACE.SAVER(TM) VOLUMETRIC PUMP MODEL 599	Aug 28, 1989	Substantially Equivalent	Y
K892210	MULTI-DRUG(TM) INFUSION SYSTEM	Aug 28, 1989	Substantially Equivalent	I-Flow Corp.
K883645	LIFECARE MICRO PUMP	Aug 17, 1989	Substantially Equivalent	Abbott Laboratories
K890862	AMBULATORY INFUSION PUMP	Aug 03, 1989	Substantially Equivalent	Medfusion, Inc.
K890786	IVSK09 CALIBRATION KIT AN ACCESSORY TO IV7000/7200	Jul 28, 1989	Substantially Equivalent	Valleylab, Inc.
K890120	SYRINGE INFUSION PUMP	Jul 27, 1989	Substantially Equivalent	Medfusion, Inc.
K892906	60 MICROBORE EXTENSION SET W/ANTI-SIPHON VALVE	Jul 25, 1989	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K884505	BASAL/BOLUS INFUSORS	Jul 14, 1989	Substantially Equivalent	Baxter Healthcare Corp
K891583	IVAC VARIABLE PRESSURE VOLUMETRIC PUMP, 570 SERIES	Jun 09, 1989	Substantially Equivalent	Y
K890783	GRIESHABER VISCOELASTIC INJECTION SYSTEM	May 16, 1989	Substantially Equivalent	Grieshaber & Co.
K890282	RESUBMITTED ABBOTT LIFECARE MODEL 3 HB PUMP	Apr 19, 1989	Substantially Equivalent	Abbott Laboratories
K883609	ACCES. PACKAGE FOR USE W/CARDIOGEN-82 GENERATOR	Apr 14, 1989	Substantially Equivalent	Squibb Diagnostics
K890062	CADD-PCA MODEL 5800 AMBULATORY INFUSION PUMP	Mar 23, 1989	Substantially Equivalent	Pharmacia Deltec, Inc.
K890457	MODIFIED MINIMED MDL404-SP/504-S DRUG INSULIN PUMP	Mar 08, 1989	Substantially Equivalent	Medtronic Minimed
K883796	LIFECARE MICRO PUMP	Feb 28, 1989	Substantially Equivalent	Abbott Laboratories
K882249	M.I.P. - PUMP	Feb 28, 1989	Substantially Equivalent	Intro-Med, Inc.
K881759	BT-1 INFUSION PUMP	Feb 28, 1989	Substantially Equivalent	Ferring Laboratories, Inc.
K885083	INFUSA-PLATE(TM) EX	Feb 27, 1989	Substantially Equivalent	Kalayjian Ent.
K883993	MODIFIED IMED GEMINI PC-1 INFUSION PUMP	Dec 19, 1988	Substantially Equivalent	Imed Corp.
K884014	FLO-GARD VP	Dec 12, 1988	Substantially Equivalent	Baxter Healthcare Corp
K883577	BARD INFUSOR PUMP	Nov 18, 1988	Substantially Equivalent	C.R. Bard, Inc.
K883587	BIOSEARCH 3600 ENTRI FEEDING PUMP	Nov 08, 1988	Substantially Equivalent	Biosearch Medical Products, Inc.
K883653	EP-100 INFUSION PUMP	Nov 01, 1988	Substantially Equivalent	Stereotactic Medical Systems, Inc.
K882598	250 ML BAG W/Y INJECT. & 12 EXTENSION SET	Nov 01, 1988	Substantially Equivalent	Prn Services, Inc.
K883902	INFUSA-PLATE	Oct 27, 1988	Substantially Equivalent	Kalajian Ent.
K881079	UVP VOLUMED 2001	Oct 25, 1988	Substantially Equivalent	Ferguson Medical
K883003	MULTI-DRUG INFUSION SYSTEM	Oct 14, 1988	Substantially Equivalent	I-Flow Corp.
K882594	THE OMNI-FLOW THERAPIST INFUSION MANAGEMENT SYSTEM	Sep 20, 1988	Substantially Equivalent	Omni-Flow, Inc.
K882556	BECTON DICKINSON PCA INFUSER - SOFTWARE MODIFI.	Sep 15, 1988	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K880857	SYRINGE PUMP MS2000	Sep 01, 1988	Substantially Equivalent	Smash Ent., Inc.
K882159	522 INTELLIGENT PUMP	Aug 24, 1988	Substantially Equivalent	Kendall Mcgaw Laboratories, Inc.
K882102	PROVIDER ONE INFUSION SYSTEM	Aug 12, 1988	Substantially Equivalent	Pancretec, Inc.
K882107	PERFUSOR SECURA SYRINGE PUMP	Aug 11, 1988	Substantially Equivalent	Burron Medical, Inc.
K882106	PERFUSOR M SYRINGE PUMP	Aug 11, 1988	Substantially Equivalent	Burron Medical, Inc.
K882047	ENTRUST(TM) MODEL 800	Aug 11, 1988	Substantially Equivalent	Avi, Inc.
K880733	BARD PCA II INFUSION PUMP	Jun 20, 1988	Substantially Equivalent	C.R. Bard, Inc.
K881590	ADFUSE(TM)	May 23, 1988	Substantially Equivalent	Healthtek, Inc.
K875332	IVAC VOLUMETRIC PUMP - MODEL 590	May 20, 1988	Substantially Equivalent	Y
K875316	BIONICA MDS 110 PCA	May 11, 1988	Substantially Equivalent	Bionica, Inc.
K874546	SIM MODULE	May 11, 1988	Substantially Equivalent	Critikon Company, LLC
K875365	MODEL 200A INFUSION PUMP	Apr 29, 1988	Substantially Equivalent	Avi, Inc.
K875348	MODEL 400A INFUSION PUMP	Apr 29, 1988	Substantially Equivalent	Avi, Inc.
K875347	MODEL 210A INFUSION PUMP	Apr 29, 1988	Substantially Equivalent	Avi, Inc.
K880479	IMED(R) GEMINI(TM) PC-1 VOLUMETRIC INFUSION PUMP	Apr 25, 1988	Substantially Equivalent	Imed Corp.
K880204	CADD-TPA(TM) MODEL 5600 AMBULATORY INFUSION PUMP	Apr 25, 1988	Substantially Equivalent	Pharmacia Deltec, Inc.
K880623	MINIMED MODEL 404-SP EXTERNAL INFUSION PUMP	Apr 21, 1988	Substantially Equivalent	Medtronic Minimed
K880569	TEAMMATE(TM)	Apr 21, 1988	Substantially Equivalent	Infusion Systems Corp.
K880625	HALF HOUR INFUSOR	Apr 19, 1988	Substantially Equivalent	Baxter Healthcare Corp
K875364	MODIFIED PCA INFUSER	Apr 13, 1988	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K875174	RATEMINDER V INFUSION PUMP	Mar 29, 1988	Substantially Equivalent	Critikon Company, LLC
K874181	BAXTER BEDSIDE SYSTEM	Feb 22, 1988	Substantially Equivalent	Travenol Laboratories, S.A.
K874564	MINIMED III INFUSION PUMP & UNI-SET ADMIN SET	Feb 11, 1988	Substantially Equivalent	Medtronic Minimed
K874649	CADD-PLUS(TM) MODEL 5400 AMBULATORY INFUSION PUMP	Jan 19, 1988	Substantially Equivalent	Pharmacia Deltec, Inc.
K873884	IVAC MODEL 560+ SERIES VOLUMETRIC INFUSION PUMP	Jan 06, 1988	Substantially Equivalent	Y
K873746	AUTO SYRINGE MODEL AS20G INFUSION PUMP	Jan 06, 1988	Substantially Equivalent	Baxter Healthcare Corp
K871881	MODEL 3000 INFUSION PUMP	Jan 06, 1988	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K872774	BETATRON IV SYSTEM	Jan 05, 1988	Substantially Equivalent	Cardiac Pacemakers, Inc.
K873495	PUMP TUBING SET	Dec 30, 1987	Substantially Equivalent	Marquette Medical, Inc.
K873494	RESERVOIR BAG	Dec 30, 1987	Substantially Equivalent	Marquette Medical, Inc.
K873961	INFUMED 300 AMBULATORY INFUSION PUMP	Dec 29, 1987	Substantially Equivalent	Med Fusion Systems, Inc.
K873522	BARD AMBULATORY PCA DRUG DELIVERY SYSTEM	Dec 29, 1987	Substantially Equivalent	C.R. Bard, Inc.
K872516	INFUSION PUMP MODEL 275	Dec 16, 1987	Substantially Equivalent	Avi, Inc.
K872515	INFUSION PUMP MODEL 470	Dec 16, 1987	Substantially Equivalent	Avi, Inc.
K872514	INFUSION PUMP MODEL 270	Dec 16, 1987	Substantially Equivalent	Avi, Inc.
K871807	BARD MICROINFUSER I INSULIN INFUSION PUMP	Dec 16, 1987	Substantially Equivalent	C.R. Bard, Inc.
K873938	IVAC(R) DUAL RATE SET - MODEL C50066	Dec 11, 1987	Substantially Equivalent	Y
K873847	CORMED III AMBULATORY INFUSION PUMP	Dec 07, 1987	Substantially Equivalent	C.R. Bard, Inc.
K873776	IVAC(R) STAR-FLOW(TM) VOLUMETRIC PUMP - MODEL 580+	Dec 03, 1987	Substantially Equivalent	Y
K873875	BAXA EXACTA-MED PHARMACY PUMP	Nov 24, 1987	Substantially Equivalent	Baxa Corp., Sub. of Cook Group, Inc.
K873161	VALLEYLAB MODEL IV7200 INFUSION PUMP	Nov 05, 1987	Substantially Equivalent	Valleylab, Inc.
K872764	IVAC NITROGLYCERIN & LIPID ADMIN. SET MODEL S75053	Nov 03, 1987	Substantially Equivalent	Y
K873444	ENTECH ENTERAL PUMP AND SET	Nov 02, 1987	Substantially Equivalent	Entech, Inc.
K871806	PROVIDER IV. MODEL 5000 INFUSION DEVICE	Oct 22, 1987	Substantially Equivalent	Pancretec, Inc.
K872952	ULTRASONIC AIR-IN-LINE DETECTOR (AILD)	Oct 20, 1987	Substantially Equivalent	Imed Corp.
K872741	NUTRIPUMP	Oct 20, 1987	Substantially Equivalent	I M, Inc.
K870656	IMED(R) 980C VOLUMETRIC INFUSION PUMP	Oct 20, 1987	Substantially Equivalent	Imed Corp.
K870801	FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD	Sep 04, 1987	Substantially Equivalent	Travenol Laboratories, S.A.
K872850	RATE INFUSER SYSTEM	Aug 14, 1987	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K872821	INFUSION PUMP ENCLOSURE	Jul 27, 1987	Substantially Equivalent	Pharmacia Deltec, Inc.
K871728	MODIFIED LIFECARE(R) 4100 PCA INFUSER	Jul 27, 1987	Substantially Equivalent	Abbott Laboratories
K871084	NITROGLYCERINE PUMP SET	Jul 16, 1987	Substantially Equivalent	Churchill Corp.
K870330	SP55 SYRINGE PUMP	Jun 15, 1987	Substantially Equivalent	Vickers , Ltd.
K870992	IMED(R) MODEL 965A VOLUMETRIC INFUSION PUMP	Jun 04, 1987	Substantially Equivalent	Imed Corp.
K870991	IMED(R) MODEL 960A VOLUMETRIC INFUSION PUMP	Jun 04, 1987	Substantially Equivalent	Imed Corp.
K870524	AMBULATORY INFUSION PUMP DRUG RESERVOIR	May 06, 1987	Substantially Equivalent	Med Fusion Systems, Inc.
K870444	HOMEPRO II VOLUMETRIC INFUSION PUMP	Apr 17, 1987	Substantially Equivalent	American Edwards Laboratories
K870279	VP2000 INFUSION PUMP	Mar 25, 1987	Substantially Equivalent	Vickers , Ltd.
K864276	PERSONAL INFUSION PUMP	Mar 17, 1987	Substantially Equivalent	Bionica, Inc.
K870768	AC ADAPTER ACCESSORY, PRODUCT CODE 600123A	Mar 13, 1987	Substantially Equivalent	Deltec Systems, Inc.
K870242	INTERMATE(TM)	Mar 13, 1987	Substantially Equivalent	Infusion Systems Corp.
K864997	MEDTRAC VP VOLUMETRIC INFUSION PUMP	Feb 27, 1987	Substantially Equivalent	American Edwards Laboratories
K865051	GRASEBY PCAS MODEL NO. 0124-0701, PVS DYTINHR PUMP	Feb 10, 1987	Substantially Equivalent	Panamedix, Inc.
K864809	IVAC(R) STAR-FLOW(TM) VOLUMETRIC PUMP - MODEL 580	Feb 10, 1987	Substantially Equivalent	Y
K865060	I.V. SET WITH DUAL-CHANNEL CASSETTE	Feb 06, 1987	Substantially Equivalent	Abbott Laboratories
K865059	I.V. SET W/SINGLE-CHANNEL CASSETTE	Feb 06, 1987	Substantially Equivalent	Abbott Laboratories
K865058	ABBOTT LIFECARE (R) 5000, PUMP SYSTEM	Feb 06, 1987	Substantially Equivalent	Abbott Laboratories
K863864	AMBULATORY INFUSION PUMP, MODEL AS30C	Feb 04, 1987	Substantially Equivalent	Travenol Laboratories, S.A.
K864808	STRATO(R) PCA INFUSER	Jan 21, 1987	Substantially Equivalent	Strato Medical Corp.
K864227	PERCUPUMP (TM)	Jan 16, 1987	Substantially Equivalent	E-Z-Em, Inc.
K863532	MODIFIED LABELING TO MODEL 2000 AMBULATORY INFUSER	Jan 14, 1987	Substantially Equivalent	Parker Hannifin Corp.
K864233	BARD HARVARD MINI-INFUSER 950 PUMP	Jan 12, 1987	Substantially Equivalent	C.R. Bard, Inc.
K863470	DALTEX IV INFUSION PUMP	Jan 05, 1987	Substantially Equivalent	Daltex Medical Sciences, Inc.
K864138	MINIMED MODEL 404-S EXTERNAL INFUSION PUMP	Dec 29, 1986	Substantially Equivalent	Medtronic Minimed
K864517	MODEL 504-S EXTERNAL INFUSION PUMP FOR DIABETICS	Dec 12, 1986	Substantially Equivalent	Medtronic Minimed
K863997	ABBOTT LIFECARE(R) 4100 PCA INFUSER	Dec 12, 1986	Substantially Equivalent	Abbott Laboratories
K864106	SR-MODEL 230 (MODIFICATION)	Nov 19, 1986	Substantially Equivalent	Hirata Sangyo Co. USA, Inc.
K863683	BARD HARVARD(TM) PCA JR INTERMITTENT INFUSION PUMP	Oct 07, 1986	Substantially Equivalent	C.R. Bard, Inc.
K862295	MODEL PC-2 VOLUMETRIC INFUSION PUMP/CONTROLLER	Sep 23, 1986	Substantially Equivalent	Imed Corp.
K860353	SYRINGE INFUSION PUMP	Sep 05, 1986	Substantially Equivalent	Travenol Laboratories, S.A.
K862927	CADD-1, MODEL 5100 HF	Aug 27, 1986	Substantially Equivalent	Deltec Systems, Inc.
K861539	NIKKISO INFUSION PUMP MODEL PFA-02	Jul 31, 1986	Substantially Equivalent	International Medical Products, Inc.
K861598	INTELLIGRAPH(TM) PROGRAMMER	Jul 24, 1986	Substantially Equivalent	Intelligent Medicine, Inc.
K861208	INTELLIJECT MEDICATION SYRINGE	Jun 30, 1986	Substantially Equivalent	Intelligent Medicine, Inc.
K861207	INTELLIJECT INFUSION PUMP	Jun 30, 1986	Substantially Equivalent	Intelligent Medicine, Inc.
K861209	STREAM-SWITCH MANIFOLD	Jun 23, 1986	Substantially Equivalent	Intelligent Medicine, Inc.
K861040	ENTERNAL INFUSER MULTIPUMP 203	Jun 23, 1986	Substantially Equivalent	Medix Medical Electronics (U.S.A.), Inc.
K861001	PARENTERAL INFUSER MEDIPUMP 204	Jun 12, 1986	Substantially Equivalent	Medix Medical Electronics (U.S.A.), Inc.
K861436	SOF SET, MODELS 111 AND 112	Jun 09, 1986	Substantially Equivalent	Pacesetter Systems
K861324	PATIENTCARE 1000	Jun 09, 1986	Substantially Equivalent	Criticare Technologies Corp.
K860222	70 ML RESERVOIR BAG AND ADMINISTRATION SETS	Jun 09, 1986	Substantially Equivalent	Prn Services, Inc.
K860857	SOF SET, MODELS 113 AND 114	May 27, 1986	Substantially Equivalent	Pacesetter Systems
K861007	BECTON DICKINSON PCAINFUSER	May 20, 1986	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K860969	FLUID MANAGEMENT SYSTEM (MODIFIED)	May 06, 1986	Substantially Equivalent	Haemonetics Corp.
K860694	IV7200 AND IV7400 INFUSION PUMP	Apr 22, 1986	Substantially Equivalent	Valleylab, Inc.
K860162	FLO-GARD 6200 VOLUMETRIC INFUSION PUMP	Apr 18, 1986	Substantially Equivalent	Travenol Laboratories, S.A.
K860229	MODEL 900 INFUSION PUMP	Apr 09, 1986	Substantially Equivalent	C.R. Bard, Inc.
K860218	SYRINGE PUMP: VM 07	Apr 07, 1986	Substantially Equivalent	Vial Medical , Ltd.
K860086	ENTERAL NUTRITION PUMPS PN 1000 AND VM 05	Mar 24, 1986	Substantially Equivalent	Vial Medical , Ltd.
K854318	LIFEPORT AMBULATORY INFUSION PUMP	Mar 18, 1986	Substantially Equivalent	Strato Medical Corp.
K853664	HEPARIN MICRO-INFUSOR	Mar 18, 1986	Substantially Equivalent	Y
K852168	ELECTRONIC COMMUNICATION SYS ACCESSORY FOR GRAVITY	Mar 12, 1986	Substantially Equivalent	Y
K854964	CADD-LD 5500 AMBU INFUSION PUMP&3010 10ML MED RES.	Mar 07, 1986	Substantially Equivalent	Deltec Systems, Inc.
K860502	G.A.S./GRIESHABER AIR SYSTEM	Feb 27, 1986	Substantially Equivalent	Grieshaber & Co.
K855215	AIR/FLUID EXCHANGE SYSTEM	Feb 27, 1986	Substantially Equivalent	Mira, Inc.
K860492	NORDISK INFUSER SYSTEM WITH PRE-FILLED CARTRIDGE	Feb 19, 1986	Substantially Equivalent	Nordisk Infuser System
K854157	PMT ACCUPRESSURE INFUSION SYSTEM 3601	Feb 13, 1986	Substantially Equivalent	Progress Mankind Technology
K853629	BARD HARVARD CHRONOFUSOR TIME-DOSE SYRINGE INFUSIO	Jan 27, 1986	Substantially Equivalent	C.R. Bard, Inc.
K853814	MP0400 ADULT, PERISTALIC INFUSION PUMP	Jan 16, 1986	Substantially Equivalent	Medex, Inc.
K854074	MODEL 200 INFUSION PUMP	Dec 10, 1985	Substantially Equivalent	Avi, Inc.
K854073	MODEL 210 INFUSION PUMP	Dec 10, 1985	Substantially Equivalent	Avi, Inc.
K852645	FLUID MANAGEMENT SYSTEM	Dec 09, 1985	Substantially Equivalent	Haemonetics Corp.
K853881	THE TRAVENOL 5 ML/HR INFUSOR	Dec 02, 1985	Substantially Equivalent	Travenol Laboratories, S.A.
K853393	INSULIN PUMP INSUMAT 229	Nov 18, 1985	Substantially Equivalent	Medix Medical Electronics (U.S.A.), Inc.
K850792	ODAC-ON DEMAND ARALGESIA BY COMPUTER-INFUSION PUMP	Nov 13, 1985	Substantially Equivalent	Janssen Pharmaceutica, Inc.
K853584	CADD-1, MODEL 5100 HF, AMBULATORY INFUSION PUMP	Nov 12, 1985	Substantially Equivalent	Deltec Systems, Inc.
K853134	NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8	Nov 06, 1985	Substantially Equivalent	Erika, Inc.
K842905	TRAVENOL MULTIDAY INFUSOR 2C1080	Nov 01, 1985	Substantially Equivalent	Travenol Laboratories, S.A.
K852965	ENTERAL FEEDING PUMP	Aug 21, 1985	Substantially Equivalent	Empire Industries, Inc.
K852358	SYRINGE INFUSION PUMP - AS 20 SERIES	Jul 05, 1985	Substantially Equivalent	Baxter Healthcare Corp
K851821	VI-FLOW PUMP WITH VI-SET	Jul 05, 1985	Substantially Equivalent	Vital Canada, Inc.
K852073	VIAL SYRINGE PUMPS, SE200, SE200B & SE400	Jun 07, 1985	Substantially Equivalent	Hospal Medical Corp.
K852060	INFUSION SETS MODELS 9120,9121,9125, 9122 & 9123	Jun 07, 1985	Substantially Equivalent	Cardiac Pacemakers, Inc.
K851564	MODEL 2000 INDULIN INFUSION PUMP	May 30, 1985	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K851351	ENTERAL FEEDING PUMP	May 30, 1985	Substantially Equivalent	Empire Industries, Inc.
K850997	UVP 2000 VOLUMED -TENTATIVE	May 13, 1985	Substantially Equivalent	Sterling Medical Devices, Inc.
K851447	IVAC MODEL 580 GENER. USE VOLUMETRIC INFUSION PUMP	May 08, 1985	Substantially Equivalent	Y
K851360	IMED GRAVISET INTRAVASCULAR ADMIN. SET	May 08, 1985	Substantially Equivalent	Imed Corp.
K851017	QUEST 521 VARIABLE PRESSURE VOLUMETRIC INFUSION PU	May 07, 1985	Substantially Equivalent	Quest Medical, Inc.
K850729	ACUFLO VOLUMETRIC CONTROLLED DELIVERY SYS 2000	Apr 09, 1985	Substantially Equivalent	Surgidev Corp.
K850674	CORMED II AMBULATORY INFUSION PUMP	Apr 09, 1985	Substantially Equivalent	Cormed, Inc., Sub. C.R.Bard, Inc.
K850669	PROMINJECT PROGRAMMABLE INFUSION PUMP	Apr 09, 1985	Substantially Equivalent	Pharmacia, Inc.
K850653	IMED 440 INFUSION PUMP & ADMINISTRATION SET	Apr 09, 1985	Substantially Equivalent	Imed Corp.
K850488	STRATOFUSE SYRINGE PIGGYBACK PUMP 1030	Mar 21, 1985	Substantially Equivalent	Strato Medical Corp.
K850183	CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M	Mar 13, 1985	Substantially Equivalent	Deltec Systems, Inc.
K843311	IV ADMIN. SET FOR MVP 1 INFUSION PUMP	Mar 13, 1985	Substantially Equivalent	Ziehm International, Inc.
K844401	REPRO-MED SYSTEMS INFUSION DEVICE	Mar 12, 1985	Substantially Equivalent	Repro-Med Systems, Inc.
K844915	IMED 980 VOLUMETRIC INFUSION PUMP	Mar 06, 1985	Substantially Equivalent	Imed Corp.
K850098	SILVER SPOON ENTERAL FEEDING PUMP	Feb 22, 1985	Substantially Equivalent	Sterling Medical Devices, Inc.
K841374	HOME PRO VOLUMETRIC INFUSION PUMP	Feb 15, 1985	Substantially Equivalent	American Edwards Laboratories
K844730	BARD HARVARD MINI-INFUSER 400 MULTI DOSE SYRINGE	Jan 28, 1985	Substantially Equivalent	C.R. Bard, Inc.
K844719	360 INFUSER	Jan 28, 1985	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K844718	MODEL 1001	Jan 28, 1985	Substantially Equivalent	A0kfusion Systems, Inc.
K844627	STRATOFUSE SYRINGE PIGGYBACK PUMP	Jan 28, 1985	Substantially Equivalent	Strato Medical Corp.
K844768	ABBOTT LIFECARE 500 INFUSER	Jan 25, 1985	Substantially Equivalent	Abbott Laboratories
K844091	ABBOTT LIFECARE 900 VOLUMETRIC PUMP	Jan 25, 1985	Substantially Equivalent	Abbott Laboratories
K844851	MINIMED EXTERNAL INFUSION PUMP FOR DIAGETICS 504	Jan 22, 1985	Substantially Equivalent	Pacesetter Systems
K844792	MINIMED EXTERNAL INFUSION PUMP FOR DIABETICS 502A	Jan 22, 1985	Substantially Equivalent	Pacesetter Systems
K844078	PROVIDER PA 3000 INFUSION SYSTEM	Dec 18, 1984	Substantially Equivalent	Pancretec, Inc.
K843878	HEPARIN INFUSIN PUMP	Dec 06, 1984	Substantially Equivalent	Armament Systems, Inc.
K843773	CADD-PAC 5200 AMBULATORY INFUSION PUMP	Dec 06, 1984	Substantially Equivalent	Deltec Systems, Inc.
K843772	CADD-1 5100 AMBULATORY INFUSION PUMP	Dec 06, 1984	Substantially Equivalent	Deltec Systems, Inc.
K843949	I.V. PUMP ADMINISTRATION SET	Nov 30, 1984	Substantially Equivalent	Travenol Laboratories, S.A.
K843331	INTERMEDICS/GRASEBY DYNAMICS MS 36	Nov 15, 1984	Substantially Equivalent	Intermedics, Inc.
K842479	I.V. TEAMATE	Nov 02, 1984	Substantially Equivalent	Medical Delivery Systems
K843616	AVI GUARDIAN 400 INFUSION PUMP	Oct 31, 1984	Substantially Equivalent	Avi, Inc.
K843615	AVI GUARDIAN MICRO 410 INFUSION PUMP	Oct 31, 1984	Substantially Equivalent	Avi, Inc.
K843548	INTERMEDICS SYRINGE PUMP 710-02	Oct 31, 1984	Substantially Equivalent	Intermedics, Inc.
K843168	ENTERAL FEEDING PUMP 14-800 SERIES	Oct 24, 1984	Substantially Equivalent	Biosearch Medical Products, Inc.
K843274	MODULAR VOLUMETRIC INFUSION PUMP SYS	Oct 19, 1984	Substantially Equivalent	American Edwards Laboratories
K842568	RADIONUCLIDE INFUSION SYSTEM	Oct 19, 1984	Substantially Equivalent	Squibb Diagnostics
K842421	ARGYLE ENTERITE ENTERAL FEEDING PUMP	Aug 17, 1984	Substantially Equivalent	Sherwood Medical Co.
K841827	ENTEROPORT NUTRITION PUMP	Jul 27, 1984	Substantially Equivalent	Diatek, Inc.
K842289	SR- MODEL 230	Jul 25, 1984	Substantially Equivalent	Hirata Sangyo Co. USA, Inc.
K842263	MTP E.V. INFUSION PUMP	Jul 25, 1984	Substantially Equivalent	Ziehm International, Inc.
K842027	IVAC 3080 ENTERAL FEEDING PUMP	Jul 18, 1984	Substantially Equivalent	Y
K841922	ACCUPRO VOLUMETRIC INFUSION PUMP W/RS232	Jul 13, 1984	Substantially Equivalent	American Edwards Laboratories
K841784	FLEXIFLO-III PORTABLE ENTERAL NUTRI	Jun 07, 1984	Substantially Equivalent	Abbott Laboratories
K841630	ENTERAL NUTRITION PUMP	Jun 07, 1984	Substantially Equivalent	Superior Plastic Products Corp.
K841729	ACCUPRO ENTERAL FEEDING PUMP	Jun 01, 1984	Substantially Equivalent	American Mcgaw
K841512	ETHOX RELIA-FLO 2001 ENTERAL FEED	May 21, 1984	Substantially Equivalent	Ethox Corp.
K841481	WINDSOR MEDICAL MODEL 50-00002	May 21, 1984	Substantially Equivalent	Windsor Medical, Inc.
K841373	PROVIDER IV MODEL 2000 INFUSIN SYS	May 14, 1984	Substantially Equivalent	Pancretec, Inc.
K841017	PROVIDER INFUSION SET	Apr 30, 1984	Substantially Equivalent	Pancretec, Inc.
K833983	PROVIDER U-100 INSULIN INFUSION SYS	Apr 13, 1984	Substantially Equivalent	Pancretec, Inc.
K841018	PANCRETEC PUMP CHECK	Apr 05, 1984	Substantially Equivalent	Pancretec, Inc.
K840616	MINI-PUMP U-100	Mar 30, 1984	Substantially Equivalent	Advanced Bio Systems, Inc.
K832470	INFUSION PUMP	Feb 28, 1984	Substantially Equivalent	Delta Medical Industries
K840263	LIFECARE 4/HOMECARE - 4H PUMP	Feb 27, 1984	Substantially Equivalent	Abbott Laboratories
K834461	INFUSION PUMP PRIMER	Jan 30, 1984	Substantially Equivalent	Parker Hannifin Corp.
K833723	MODEL 2000 AMBULATORY MED. INFUSER	Jan 30, 1984	Substantially Equivalent	Parker Hannifin Corp.
K833958	FLO-GARD 8100 INFUSION PUMP	Dec 29, 1983	Substantially Equivalent	Travenol Laboratories, S.A.
K833655	GILLETTE SABRE SYRINGE	Dec 29, 1983	Substantially Equivalent	Intermedics, Inc.
K832285	VOLUMETRIC PUMP SET 2C9100 FOR NITROGLY	Dec 27, 1983	Substantially Equivalent	Travenol Laboratories, S.A.
K832606	WINDSOR MEDICAL VARIOUS MODELS	Nov 29, 1983	Substantially Equivalent	Windsor Medical, Inc.
K833306	BETATRON I AMBULATORY INSULIN PUMP	Nov 28, 1983	Substantially Equivalent	Cardiac Pacemakers, Inc.
K832350	INTRABIONIC CO. - MICRO SYRINGE	Nov 28, 1983	Substantially Equivalent	Intrabionic Co.
K832349	PROGRAMED	Nov 28, 1983	Substantially Equivalent	Intrabionic Co.
K832923	AMBULATORY INSULIN INFUSION PUMP	Nov 03, 1983	Substantially Equivalent	Caridac Pacemakers, Inc.
K832755	INFUSION PUMP & IV SETS #4000	Nov 03, 1983	Substantially Equivalent	Omni-Glow, Inc.
K832641	WINDSOR MEDICAL MODEL 52	Oct 04, 1983	Substantially Equivalent	Windsor Medical, Inc.
K830657	AMBULATORY MARK XI DRUG INFUSION DEV-	Sep 16, 1983	Substantially Equivalent	Windsor Medical, Inc.
K832410	GRASEBY DYNAMICS MS302 SYRINGE DRIVER	Sep 12, 1983	Substantially Equivalent	Intermedics, Inc.
K832289	LIFECARE MICRO PUMP	Sep 12, 1983	Substantially Equivalent	Abbott Laboratories
K831534	PUMPETTE AS8P-INFUSION PUMP	Sep 12, 1983	Substantially Equivalent	Travenol Laboratories, S.A.
K831444	SINGLE USE SYRINGE #103 PERSONAL MEDIC	Sep 12, 1983	Substantially Equivalent	Pacesetter Systems
K830389	ACCU-RYNGE PUMP SP-250	Sep 12, 1983	Substantially Equivalent	Delta Medical Industries
K832167	CORPAK VTR 300 ENTERNAL PUMP	Aug 16, 1983	Substantially Equivalent	Corpak Co.
K832166	FLO-GARD 8500 MICROINFUSION PUMP	Aug 16, 1983	Substantially Equivalent	Travenol Laboratories, S.A.
K830656	AMBULATORY MARK III INFUSION DEVICE	Aug 16, 1983	Substantially Equivalent	Windsor Medical, Inc.
K832120	PROMINJET PUMP	Aug 12, 1983	Substantially Equivalent	Abbott Laboratories
K832008	INFUTROL 7000 INFUSION PUMP	Aug 12, 1983	Substantially Equivalent	Valleylab, Inc.
K831897	BETA I PROGRAMMABLE INFUSION PUMP	Aug 12, 1983	Substantially Equivalent	Orange Medical Instruments, Inc.
K831761	SIMPLICITY PLUS	Aug 12, 1983	Substantially Equivalent	Critikon Company, LLC
K831935	ENTERNAL PUMP & ADMIN. SET 430	Aug 08, 1983	Substantially Equivalent	Imed Corp.
K831258	FLO-GARD 6100 VOLUMETRIC INFUSION PUMP	Jun 30, 1983	Substantially Equivalent	Travenol Laboratories, S.A.
K830906	PULSAMAT MODEL 1050	Jun 15, 1983	Substantially Equivalent	Ferring Laboratories, Inc.
K831203	Y-TYPE BACKCHECK MICROBORE EXTEN. SET	Jun 03, 1983	Substantially Equivalent	Abbott Laboratories
K831259	RESERVOIR 1.5CC #9210 W/25 GAUGE/NEEDLE	May 09, 1983	Substantially Equivalent	Cardiac Pacemakers, Inc.
K830809	GRASE BY DYNAMICS MS 27 SYRINGE DRIVER	Apr 14, 1983	Substantially Equivalent	Intermedics, Inc.
K830486	INFUSION PUMP #AS*6H	Apr 14, 1983	Substantially Equivalent	Baxter Healthcare Corp
K830452	PCA PUMP	Apr 14, 1983	Substantially Equivalent	Abbott Laboratories
K830936	TREONIC IP5	Apr 12, 1983	Substantially Equivalent	Vickers America Medical Corp.
K830605	PUMP PALL AMBULATORY INSULIN INFUSION	Mar 31, 1983	Substantially Equivalent	Biomedical Devices, Inc.
K830544	WINDSOR MEDICAL, INC. 50-01-028	Mar 31, 1983	Substantially Equivalent	Windsor Medical, Inc.
K830490	MODEL 50-01-27	Mar 31, 1983	Substantially Equivalent	Windsor Medical, Inc.
K830454	IMS MINIATURE VOLUMETRIC INFUSION PUMP	Mar 31, 1983	Substantially Equivalent	Ziehm International, Inc.
K830570	PERSONAL MEDICATION INFUSER	Mar 24, 1983	Substantially Equivalent	Pacesetter Systems
K822842	AMBULATORY MARK I	Mar 24, 1983	Substantially Equivalent	Windsor Medical, Inc.
K830423	SYRINGE DRIVER MS-16	Mar 07, 1983	Substantially Equivalent	Intermedics, Inc.
K830355	SECURA IV VOLUMETRIC INFUSION PUMP	Mar 01, 1983	Substantially Equivalent	Diatek, Inc.
K830102	HARVARD APPARATUS INTERMITTENT INFUSION	Feb 28, 1983	Substantially Equivalent	C.R. Bard, Inc.
K830151	EXTERNAL INFUSION PUMP	Feb 18, 1983	Substantially Equivalent	Intermedics, Inc.
K830177	HARVARD APPARATUS FAMILY OF FLUID INFUS	Feb 07, 1983	Substantially Equivalent	C.R. Bard, Inc.
K830038	SIGMA 7000-6000 INFUSION PUMPS	Jan 26, 1983	Substantially Equivalent	Sigma
K830017	VOLUMETRIC PUMP ADMIN. SETS	Jan 26, 1983	Substantially Equivalent	Travenol Laboratories, S.A.
K820038	SIGMA 7000	Jan 26, 1983	Substantially Equivalent	Sigma
K823406	GUARDIAN 110, VOL. CONTROL DELIV. SYS	Dec 22, 1982	Substantially Equivalent	Avi, Inc.
K823204	BETATRON II	Nov 30, 1982	Substantially Equivalent	Cardiac Pacemakers, Inc.
K823193	AMBULATORY INSULIN INFUSION PUMP 9205	Nov 30, 1982	Substantially Equivalent	Cpi, Inc.
K823063	FLO-GARD 2000 ENTERNAL PUMP & TRAVASORB	Nov 30, 1982	Substantially Equivalent	Travenol Laboratories, S.A.
K823035	COMPUTER INTERFACE MODULE CIM	Nov 24, 1982	Substantially Equivalent	Y
K822989	HARVARD APPARATUS SINGLE SPEED SYRINGE	Nov 03, 1982	Substantially Equivalent	C.R. Bard, Inc.
K822454	SYRINGE PUMP 209-100	Oct 18, 1982	Substantially Equivalent	Medix Corp.
K822571	SYRINGE PUMP	Oct 08, 1982	Substantially Equivalent	Hirata Sangyo Co. USA, Inc.
K822761	DELIVERY TUBE SET #2226	Sep 30, 1982	Substantially Equivalent	Delta Medical Industries
K821661	FLEXIFLO-II	Jun 22, 1982	Substantially Equivalent	Abbott Laboratories
K821069	MODEL AS6M INFUSION PUMP	Jun 10, 1982	Substantially Equivalent	Baxter Healthcare Corp
K821148	ETHOX FOOD PUMP STAND W/POLE CLAMP	May 05, 1982	Substantially Equivalent	Ethox Corp.
K821047	IVAC 630 & VOLUMETRIC INFUSION PUMP	May 03, 1982	Substantially Equivalent	Y
K820946	AS 70 VOLUMETRIC INFUSION PUMP	Apr 29, 1982	Substantially Equivalent	Narco Scientific
K820860	VOLUMETRIC PUMP CASSETTE W/ATTACHED SET	Apr 21, 1982	Substantially Equivalent	Travenol Laboratories, S.A.
K820764	IVAC MODEL 160 AIR-IN-LINE SENSOR	Apr 15, 1982	Substantially Equivalent	Y
K820726	ACCUSET (R) CASSETTE	Apr 14, 1982	Substantially Equivalent	Imed Ireland, Ltd.
K820482	ACCU-RYNGE INSULIN PUMP #SP-250	Mar 26, 1982	Substantially Equivalent	Delta Medical Industries
K813644	MODEL 2650 HIGH CAPACITY DUAL SYRINGE	Feb 18, 1982	Substantially Equivalent	Harvard Apparatus, Inc.
K820219	OPEN LOOP INFUSION PUMP	Feb 10, 1982	Substantially Equivalent	Iatric Devices
K820063	KEOFEED 500 ENTERIC FEEDING PUMP	Feb 10, 1982	Substantially Equivalent	Hedeco
K813562	SYRINGE DRIVER 209	Feb 01, 1982	Substantially Equivalent	Medix Medical Electronics (U.S.A.), Inc.
K813590	MODEL AS6B INFUSION PUMP	Jan 28, 1982	Substantially Equivalent	Baxter Healthcare Corp
K820073	OPEN LOOP AMBULATORY INSULIN INFUSION	Jan 25, 1982	Substantially Equivalent	Cardiac Pacemakers, Inc.
K813473	5B SLAVE MODULE SYRINGE PUMP	Jan 22, 1982	Substantially Equivalent	Baxter Healthcare Corp
K813455	PUMP & DETECTOR	Jan 05, 1982	Substantially Equivalent	Medlog GmbH Marketing Services
K813403	FLO-GARD 8000 INFUSION PUMP SYSTEM	Dec 31, 1981	Substantially Equivalent	Travenol Laboratories, S.A.
K812898	PE-01 ELECTRONIC INFUSION PUMP	Dec 02, 1981	Substantially Equivalent	Egnell, Inc.
K812917	PORTABLE LIDOCAINE INFUSION PUMP	Nov 06, 1981	Substantially Equivalent	Cardiac Pacemakers, Inc.
K810850	PERSONAL MEDICATION INFUSER	Nov 06, 1981	Substantially Equivalent	Pacesetter Systems
K812824	PRESSURE DISC COMPONENT FOR ACCUSET	Oct 27, 1981	Substantially Equivalent	Imed Corp.
K812823	IMED MODEL 970 & 975 VOL. INFUSION PUMP	Oct 27, 1981	Substantially Equivalent	Imed Corp.
K812499	INFUSION PUMP	Sep 16, 1981	Substantially Equivalent	Nu Tech Medical Systems
K812442	3M INFUSION SYSTEM	Sep 16, 1981	Substantially Equivalent	3M Company
K811783	ENDOPUMP	Sep 11, 1981	Substantially Equivalent	Medtron Development , Ltd.
K812339	TERUFUSION INFUSION PUMP MODEL STC-502	Sep 09, 1981	Substantially Equivalent	Terumo Medical Corp.
K812042	INFUSION PUMP MODEL 200/201	Jul 31, 1981	Substantially Equivalent	Medix Medical Electronics (U.S.A.), Inc.
K812021	VOLUMETRIC INFUSION PUMP	Jul 31, 1981	Substantially Equivalent	American Edwards Laboratories
K812035	IMED ACCUSET CASSETTE	Jul 28, 1981	Substantially Equivalent	Imed Corp.
K811917	I.V. ADMIN. SETS FOR THE AMP MARK IV PMP	Jul 23, 1981	Substantially Equivalent	American Medical Products, Inc.
K811933	GUARDIAN, VOLUMETRIC CONTROL DELIVERY	Jul 20, 1981	Substantially Equivalent	Avi, Inc.
K811918	AMP MARK IV INFUSION PUMP	Jul 20, 1981	Substantially Equivalent	American Medical Products, Inc.
K811884	IVAC 700 SYRINGE INFUSION PUMP	Jul 20, 1981	Substantially Equivalent	Y
K811774	OPEN LOOP AMBULATORY INFUSION DEVICE	Jul 10, 1981	Substantially Equivalent	Cardiac Pacemakers, Inc.
K811739	ENTRI ENTERAL FEEDING PUMP	Jul 10, 1981	Substantially Equivalent	Biosearch Medical Products, Inc.
K811272	RAZEL MODEL C	Jul 10, 1981	Substantially Equivalent	Razel Scientific Instruments, Inc.
K803183	OFFENBACK REVERSIBLE BARIUM PUMP	Jun 09, 1981	Substantially Equivalent	The Offenback Co.
K811238	MODEL 560 SERIES VOLUMETRIC INFUSION	Jun 02, 1981	Substantially Equivalent	Y
K810295	COMPUTER INTERFACE MODULE	Mar 20, 1981	Substantially Equivalent	Y
K810252	STUMARK INFUSOR	Mar 17, 1981	Substantially Equivalent	Stumark Corp.
K803078	SIMPLICITY INFUSION PUMP MODEL 2100A	Jan 28, 1981	Substantially Equivalent	Critikon Company, LLC
K803190	ETHOX/BARRON #2000 FOOD PUMP-ENTERAL FED	Jan 09, 1981	Substantially Equivalent	Ethox Corp.
K802901	TRAVENOL INFUSION PUMP-2M8016	Dec 17, 1980	Substantially Equivalent	Travenol Laboratories, S.A.
K802400	MS 16 SYRINGE DRIVER	Dec 16, 1980	Substantially Equivalent	Princeton Medical Instruments, Inc.
K802820	TRAVENOL 24 HR. INFUSOR (ELASTOMERIC PP)	Dec 10, 1980	Substantially Equivalent	Travenol Laboratories, S.A.
K802301	CORDIS DOW INFUSION PUMP	Oct 23, 1980	Substantially Equivalent	Cordis Corp.
K801904	SYRINGE INFUSION PUMP #2716	Aug 27, 1980	Substantially Equivalent	Harvard Apparatus, Inc.
K801546	THE SIMPLICITY PUMP #2100 INFUSION PUMP	Aug 27, 1980	Substantially Equivalent	Critikon Company, LLC
K801725	KANGAROO ENTERAL FEEDING PUMP	Aug 13, 1980	Substantially Equivalent	Chesebrough-Pond'S U.S.A. Co.
K801704	OPEN-LOOP INSULIN DELIVERY SYSTEM	Aug 13, 1980	Substantially Equivalent	Delta Medical Industries
K801441	ABBOTT/SHAW LIFE CARE PUMP MODEL 3	Aug 12, 1980	Substantially Equivalent	Abbott Laboratories
K800627	AMBULATORY INFUSION PUMP, CODE 2M9807	Jul 14, 1980	Substantially Equivalent	Travenol Laboratories, S.A.
K800629	INTRAVENOUS INFUSION PUMP, CODE 2M8015	May 14, 1980	Substantially Equivalent	Travenol Laboratories, S.A.
K800570	HEPARIN PUMP #7420	Apr 16, 1980	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K800569	SYRINGE INFUSION PUMP #2720	Apr 08, 1980	Substantially Equivalent	Harvard Apparatus, Inc.
K792050	3M SMALL VOLUME INFUSTION (SVI) SYSTEM	Mar 10, 1980	Substantially Equivalent	3M Company
K792142	MODEL IV 6500 FORMULATOR	Nov 29, 1979	Substantially Equivalent	Valleylab, Inc.
K791293	BATTERY POWERED SYRINGE INFUSION PUMP	Nov 13, 1979	Substantially Equivalent	Harvard Apparatus, Inc.
K791720	AR/MDE INFUSOR MODEL 60/2 INFUSION PUMP	Nov 05, 1979	Substantially Equivalent	Alza Corp.
K791729	SYRINGE INFUSION PUMP	Oct 01, 1979	Substantially Equivalent	Princeton Medical Instruments, Inc.
K791528	FLEXIFO ENTERAL NUTRITION PUMP	Sep 12, 1979	Substantially Equivalent	Abbott Laboratories
K790814	DELTA PUMP	Jun 27, 1979	Substantially Equivalent	Spiess Design, Inc.
K790945	MODEL 113 TREONIC IP3 DIGITAL SYRINGE PU	Jun 01, 1979	Substantially Equivalent	Vickers America Medical Corp.
K790559	ALARM	Jun 01, 1979	Substantially Equivalent	Maddak, Inc.
K790315	BLOOD CELL SEPARATOR SYSTEM CS3000	May 15, 1979	Substantially Equivalent	Travenol Laboratories, S.A.
K790373	IVAC 630 VOLUMETRIC INFUSION PUMP	Apr 10, 1979	Substantially Equivalent	Y
K790332	MODEL IV6000 INFUSION PUMP	Apr 10, 1979	Substantially Equivalent	Valleylab, Inc.
K782034	INFUSION PUMP, MODEL AS*5	Feb 27, 1979	Substantially Equivalent	Baxter Healthcare Corp
K782020	INFUSION PUMP, MODEL 5000	Jan 17, 1979	Substantially Equivalent	Sigmamotor, Inc.
K782019	CUTTER 888-00 INFUSION PUMP	Jan 17, 1979	Substantially Equivalent	Sigmamotor, Inc.
K781171	INFUSION PUMP, PEDIATRIC MODEL 301	Aug 10, 1978	Substantially Equivalent	Imed Corp.
K780705	INFUSION PUMP-MODEL 2616	May 19, 1978	Substantially Equivalent	Harvard Apparatus, Inc.
K780503	INFUSION PUMP	Apr 10, 1978	Substantially Equivalent	Air-Shields, Inc.
K780086	INFUSION APPARATUS, POWERED	Jan 30, 1978	Substantially Equivalent	Ohio Medical Products
K772094	LIFECARE I.V. PUMP - MODEL III	Dec 08, 1977	Substantially Equivalent	Abbott Laboratories
K771300	INTRAVENOUS INFUSION PUMP	Dec 08, 1977	Substantially Equivalent	Stewart-Naumann Laboratories
K771664	VOLUMETRIC INFUSION PUMP MODEL 960	Sep 12, 1977	Substantially Equivalent	Imed Corp.
K771478	INFUSION PUMP #6202	Aug 22, 1977	Substantially Equivalent	Roche Medical Electronics, Inc.
K770849	VOLUMET INFUSION PUMP, MODIFI. OF	Jul 14, 1977	Substantially Equivalent	Sigmamotor, Inc.
K770730	PUMP, INFUSION, DYNATECH/HANDLEY	Jul 11, 1977	Substantially Equivalent	Dynatech Medical Products
K770087	I.V. PUMP, ABBOTT/SHAW LIFECARE	Feb 14, 1977	Substantially Equivalent	Abbott Laboratories
K761307	AUTO SYRINGE MODEL AS-3A	Jan 06, 1977	Substantially Equivalent	Baxter Healthcare Corp
K761151	INFUSION PUMP	Dec 09, 1976	Substantially Equivalent	Travenol Laboratories, S.A.
K760718	PERISTALTIC INFUSION PUMP (2100,2101)	Oct 14, 1976	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.
K760370	INFUSION EQUIPMENT, INTRAVENOUS	Aug 23, 1976	Substantially Equivalent	Valleylab, Inc.