Product Code: LHI FDA class 2 21 CFR 880.5440

Set, I.V. Fluid Transfer

General Hospital

An I.V. fluid transfer set is a tubing and connector assembly used in hospital settings to transfer intravenous fluids from one container to another or to prepare IV admixtures, facilitating safe and sterile fluid management during patient care. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It carries product code LHI and is regulated under 21 CFR 880.5440 within the General Hospital specialty. This device is eligible for third-party review.

View on FDA

510(k)s

206

FEI Numbers

177

Registration Numbers

177

Unique Applicants

105

Years Active

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Basic Information

Product Code: LHI
Device Class: FDA class 2
Regulation Number: 880.5440
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 206 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252987	ADRx Admixture Device	Jun 12, 2026	Substantially Equivalent	Epic Medical Pte. , Ltd.
K260301	Vial Adapter	Jun 05, 2026	Substantially Equivalent	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
K250345	Medline Bag Decanter	Oct 24, 2025	Substantially Equivalent	Medline Industries, LP
K251715	FlowArt® Vial Access Device Vented	Oct 14, 2025	Substantially Equivalent	Asset Medikal
K251676	Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)	Sep 16, 2025	Substantially Equivalent	Microtek Medical, LLC
K243404	HyHub and HyHub Duo Vial Access Devices	Jul 18, 2025	Substantially Equivalent	Takeda Pharmaceuticals
K240761	Arisure® Closed Male Luer with Spike Adapter (YM060)	Mar 21, 2025	Substantially Equivalent	Yukon Medical, LLC
K243985	Rio Drug Reconstitution Transfer Device	Jan 22, 2025	Substantially Equivalent	Icu Medical, Inc.
K243486	SmartSiteTM Vented Vial Access Device	Dec 06, 2024	Substantially Equivalent	Yukon Medical, LLC
K241976	nextaro® va, 15mm, 5µm	Sep 06, 2024	Substantially Equivalent	Sfm Medical Devices GmbH
K233287	Vent Vial Adapter	Jul 26, 2024	Substantially Equivalent	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
K232987	FlowArt Valve for Vial Access	Jun 26, 2024	Substantially Equivalent	Asset Medikal Tasarim Sanayi VE Ticaret A.S.
K240940	Vial2Bag Advanced® 20mm Admixture Device	May 03, 2024	Substantially Equivalent	West Pharmaceutical Services, Inc.
K233284	Vial Adapter with Filter	May 01, 2024	Substantially Equivalent	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
K240748	nextaro® v, 20/20	Apr 16, 2024	Substantially Equivalent	Sfm Medical Devices GmbH
K233021	BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device	Mar 06, 2024	Substantially Equivalent	Care Fusion
K231071	Mix2Vial® Transfer Device	Jan 19, 2024	Substantially Equivalent	West Pharma. Services IL, Ltd.
K232875	Vial Adapter 20mm	Dec 14, 2023	Substantially Equivalent	West Pharma. Services IL, Ltd.
K230988	Vial2Bag Advanced® 13mm Admixture Device	Dec 01, 2023	Substantially Equivalent	West Pharma. Services IL, Ltd.
K232055	Vial Adapter	Oct 06, 2023	Substantially Equivalent	Shanghai Lingfu Technology Co., Ltd.
K230464	MixJect® Transfer Device	May 22, 2023	Substantially Equivalent	West Pharma. Services IL, Ltd.
K222718	Vial Adapter	Mar 10, 2023	Substantially Equivalent	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
K213513	Vented Vial Adapter 20mm	Aug 31, 2022	Substantially Equivalent	West Pharma. Services IL, Ltd.
K212525	Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices	Aug 19, 2022	Substantially Equivalent	Advcare Medical
K220856	Vial Adapter Ø13mm	Jun 21, 2022	Substantially Equivalent	Avenir Performance Européenne Medical (Apem)
K212445	freeflex+ Transfer Adapter	Jun 01, 2022	Substantially Equivalent	Fresenius Kabi AG
K212530	IVX Fluid Transfer Set	Apr 24, 2022	Substantially Equivalent	Omnicell, Inc.
K202732	SOL-CARE IV Bag Safety Connector	Nov 03, 2021	Substantially Equivalent	Sol-Millennium Medical Group
K203674	B Dispensing Line	Sep 27, 2021	Substantially Equivalent	Aea Srl
K200893	ProntoPump Sterile Tube Set	May 04, 2021	Substantially Equivalent	Ipax, Inc.
K201469	Mini Spike Plus 6/8R	Dec 09, 2020	Substantially Equivalent	B.Braun Medical, Inc.
K201415	Vial2Bag Advanced 20mm Admixture Device	Oct 21, 2020	Substantially Equivalent	West Pharmaceutical Services Az, Inc.
K192154	Rio Vial-to-Bag Drug Reconstitution Device	Apr 20, 2020	Substantially Equivalent	Icu Medical
K182819	Decanting Device	Dec 02, 2019	Substantially Equivalent	Gcmedica Enterprise Ltd.(Wuxi)
K190816	Vial Adapter Ø20 mm , Vial Adapter Ø13 mm	Nov 19, 2019	Substantially Equivalent	Avenir Performance Europeenne Medical (Apem)
K190149	Vial Adapter Ø20 mm	Oct 15, 2019	Substantially Equivalent	Avenir Performance Europeenne Medical (Apem)
K183187	nextaro Transfer System, nextaro va	Mar 15, 2019	Substantially Equivalent	Sfm Medical Devices GmbH
K173577	Guarded Luer Connector	Jun 07, 2018	Substantially Equivalent	International Medical Industries, Inc.
K162216	GRI-FILL PERISTALTIC SET	Oct 19, 2017	Substantially Equivalent	Laboratorios Grifols, S.A.
K171796	Vial Adapter 15mm	Oct 12, 2017	Substantially Equivalent	Medimop Medical Project , Ltd.
K172884	Arisure Closed Vial Adapter	Oct 03, 2017	Substantially Equivalent	Yukon Medical
K172631	Arisure Dry Spike	Sep 29, 2017	Substantially Equivalent	Yukon Medical
K170095	Vial2Bag Direct Connect	Mar 08, 2017	Substantially Equivalent	Medimop Medical Project , Ltd.
K161800	OnSite-IV	Dec 06, 2016	Substantially Equivalent	Pharmc, LLC
K160503	Vented Vial Adapter Transfer Device - 13mm	May 04, 2016	Substantially Equivalent	Medimop Medical Projects, Ltd.
K151423	APEX Compounding System Transfer Set	Feb 19, 2016	Substantially Equivalent	B.Braun Medical, Inc.
K152441	KIRO Set	Dec 04, 2015	Substantially Equivalent	Kiro Robotics S.L.
K150787	Universal Spike	Dec 02, 2015	Substantially Equivalent	B.Braun Medical, Inc.
K151963	SmartSite Vented Vial Access Device	Jul 31, 2015	Substantially Equivalent	Yukon Medical, LLC
K142600	VIAL-MATE Adaptor	Nov 19, 2014	Substantially Equivalent	Baxter Healthcare Corporation
K140730	VIAL2BAG DIRECT CONNECT	Jun 12, 2014	Substantially Equivalent	Medimop Medical Projects, Ltd.
K140442	MEDSOURCE SELECTABLE IV SET	Apr 22, 2014	Substantially Equivalent	Medsource International, LLC
K140402	MEDSOURCE IV ADMINISTRATION SET 72 MEDSOURCE IV ADMINISTRATION SET, NEEDLELESS MALE ADAPTER, MEDSOURCE IV EXTENSION SET	Apr 03, 2014	Substantially Equivalent	Medsource International, LLC
K133097	E-Z LINK	Mar 13, 2014	Substantially Equivalent	Duoject Medical Systems, Inc.
K133602	ADD-VANTAGE ADDAPTOR	Jan 24, 2014	Substantially Equivalent	Hospira, Inc.
K131646	DISPOSABLE INFUSION SET	Nov 26, 2013	Substantially Equivalent	Shanghai Jinta Medical Co., Ltd.
K132863	SMARTSITE VIALSHIELD	Oct 04, 2013	Substantially Equivalent	Yukon Medical, LLC
K130179	MP VIAL ADAPTER 13MM	Aug 08, 2013	Substantially Equivalent	Medimop Medical Projects, Ltd.
K132040	VIAL CONNECTOR 13MM CLOSED COLLAR	Jul 31, 2013	Substantially Equivalent	Medimop Medical Projects, Ltd.
K120384	PROTECTOR, INJECTOR, CONNECTOR	Sep 12, 2012	Substantially Equivalent	Bd Medical-Medical Surgical Systems
K122265	VIALOK SINGLE VIAL ACCESS DEVICE VENTED	Aug 14, 2012	Substantially Equivalent	Yukon Medical, LLC
K120424	MEDSOURCE IV ADMINSTRATION SET	Jul 11, 2012	Substantially Equivalent	Medsource International, LLC
K120150	DUAL SPIKE TRANSFER DEVICE	May 24, 2012	Substantially Equivalent	B.Braun Medical, Inc.
K121182	VIALOK NON-VENTED	May 03, 2012	Substantially Equivalent	Yukon Medical, LLC
K111577	MEDLINE VIAL DECANTER	Sep 08, 2011	Substantially Equivalent	Medline Industries, Inc.
K110023	INFUSION ADAPTER C100	Apr 12, 2011	Substantially Equivalent	Carmel Pharma Ab.
K102590	FLEBOSET DOUBLE	Jan 13, 2011	Substantially Equivalent	Laboratorios Grifols, S.A.
K101940	EQUASHIELD SYSTEM PROTECTIVE PLUS	Nov 19, 2010	Substantially Equivalent	Equashield Medical , Ltd.
K101309	EXELINT ALUMINUM HUB BLUNT NEEDLES	Oct 20, 2010	Substantially Equivalent	Exelint International, Co.
K100640	20 MMVIAL FLUID TRANSFER ADAPTER, MODEL 7E2500	Jul 22, 2010	Substantially Equivalent	B.Braun Medical, Inc.
K090917	SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM	Feb 19, 2010	Substantially Equivalent	Baxa Corp.
K093182	SET GRI-FILL 3.0	Jan 27, 2010	Substantially Equivalent	Laboratorios Grifols, S.A.
K092782	INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35,	Dec 07, 2009	Substantially Equivalent	Carmel Pharma Ab.
K092246	NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M285505	Nov 12, 2009	Substantially Equivalent	Nipro Medical Corporation
K092318	BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE	Oct 30, 2009	Substantially Equivalent	Baxter Healthcare Corporation
K091389	EQUALSHIELD LUER LOCK CONNECTOR PAIR	Oct 22, 2009	Substantially Equivalent	Plastmed, Ltd.
K083851	INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022	May 15, 2009	Substantially Equivalent	Inviro Medical Devices, Inc.
K090905	ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE	Apr 27, 2009	Substantially Equivalent	B.Braun Medical, Inc.
K090634	PHASEAL PROTECTOR P14, P21, P28 AND P50	Mar 23, 2009	Substantially Equivalent	Carmel Pharma Ab.
K083152	EQUASHIELD SYSTEM	Feb 02, 2009	Substantially Equivalent	Plastmed, Ltd.
K080976	NEXUS I.V. FLUID TRANSFER DEVICE	Nov 10, 2008	Substantially Equivalent	Nexus Medical, LLC
K082752	QUICKPIN	Sep 29, 2008	Substantially Equivalent	Laboratorios Grifols, S.A.
K080174	PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C	Apr 23, 2008	Substantially Equivalent	Cardio Med Supplies, Inc.
K070584	SMART-ROD	Apr 02, 2008	Substantially Equivalent	Duoject Medical Systems, Inc.
K072759	VIAL2BAG	Dec 13, 2007	Substantially Equivalent	Medimop Medical Projects, Ltd.
K072511	SWABABLE VIAL ADAPTER 13MM, SWABABLE VIAL ADAPTER 20MM	Dec 13, 2007	Substantially Equivalent	Medimop Medical Projects, Ltd.
K071741	TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM	Sep 24, 2007	Substantially Equivalent	Migada Plant
K062482	VENTED VIAL ADAPTER TRANSFER DEVICE	Nov 03, 2006	Substantially Equivalent	Medimop Medical Projects, Ltd.
K060866	PHASEAL - CLOSED SYSTEM FOR THE PREPARATION AND ADMINISTRATION OF PARENTERAL DRUGS	Apr 28, 2006	Substantially Equivalent	Carmel Pharma Ab.
K052790	SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD	Dec 23, 2005	Substantially Equivalent	Cardinal Health, Alaris Products
K051669	TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM	Sep 01, 2005	Substantially Equivalent	Migada Plant
K050339	SET GRI-FILL 3.0-1 WAY, 2 WAYS, MULTIPLE	Feb 25, 2005	Substantially Equivalent	Laboratorios Grifols, S.A.
K043304	Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01	Jan 14, 2005	Substantially Equivalent	Bioject Medical Technologies, Inc.
K041222	PINNACLE TPN MANAGEMENT SYSTEM TRANSFER SET	Oct 14, 2004	Substantially Equivalent	B.Braun Medical, Inc.
K042410	BAXJECT II	Oct 08, 2004	Substantially Equivalent	Baxter Healthcare Corp
K041691	CLIP 'N'JECT RECONSTITUTION SYSTEM (CLIP 'N'JECT	Aug 05, 2004	Substantially Equivalent	West Pharmaceutical Services, Inc.
K041232	GETTIG UNIVERSAL VIAL ACCESS PIN	Jul 22, 2004	Substantially Equivalent	Gettig Pharmaceutical Instrument Co.
K041564	Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01	Jul 16, 2004	Substantially Equivalent	Bioject Medical Technologies, Inc.
K040634	ROBERTSITE VIAL ADAPTER, MODEL 245700021	Mar 23, 2004	Substantially Equivalent	Halkey-Roberts Corp.
K040456	FLEBOSET MULTIPLE	Mar 09, 2004	Substantially Equivalent	Laboratorios Grifols, S.A.
K033682	SET GRI-FILL 2.0-1 WAY; 2.0-2 WAYS; LUER CONNECTION TUBE	Dec 17, 2003	Substantially Equivalent	Laboratorios Grifols, S.A.
K031861	MIX2VIAL TRANSFER DEVICE	Jul 29, 2003	Substantially Equivalent	Medimop Medical Projects, Ltd.
K024239	CHEMO DISPENSING PIN, MODEL 12495	Jan 13, 2003	Substantially Equivalent	Abbott Laboratories
K023539	STERI-SPOUTS; BAG-SPOUT, VIAL-SPOUT, TRANSFER MIXER; RAPIDFLOW, VIALFLOW, TRANSFLOW	Dec 17, 2002	Substantially Equivalent	Valumed
K023747	PHASEAL	Nov 15, 2002	Substantially Equivalent	Carmel Pharma Ab.
K022523	RAPID-FILL TUBESET, MODEL 90005	Aug 12, 2002	Substantially Equivalent	Baxa Corp.
K012189	ANGELTOUCH VENTED IV ADMINISTRATION SET	Mar 05, 2002	Substantially Equivalent	Angiplast Private , Ltd.
K013523	CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013	Jan 07, 2002	Substantially Equivalent	Shire Biologics, Inc.
K013087	SINGLE DOSE DISPENSING PIN, MODEL 2201	Nov 13, 2001	Substantially Equivalent	Alaris Medical Systems, Inc.
K010703	INTER-VIAL	Jun 25, 2001	Substantially Equivalent	Duoject Medical Systems, Inc.
K010623	RECONSTITUTION KIT & VIAL CONNECTOR	Apr 05, 2001	Substantially Equivalent	Bioject, Inc.
K002705	EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400	Mar 28, 2001	Substantially Equivalent	Baxa Corp.
K003730	CHEMO-AIDE DISPENSING PIN	Dec 20, 2000	Substantially Equivalent	Baxter Healthcare Corp
K001831	NEEDLELESS TRANSFER DEVICE	Jul 11, 2000	Substantially Equivalent	Medimop Medical Projects, Ltd.
K001368	PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER	May 12, 2000	Substantially Equivalent	Carmel Pharma Ab.
K001293	MODIFICATION TO MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PRE-ATTACHED NEEDLE	May 05, 2000	Substantially Equivalent	Medimop Medical Projects, Ltd.
K994323	KAWASUMI LABORATORIES PHILEBOTOMY SET	Mar 08, 2000	Substantially Equivalent	Kawasumi Laboratories Co., Ltd.
K000367	SECURMIX	Feb 29, 2000	Substantially Equivalent	Eurospital
K990711	CODAN CHEMOSPIKE	Apr 13, 1999	Substantially Equivalent	Codan US Corp.
K983794	CHEMO MINI SPIKE PLUS	Mar 23, 1999	Substantially Equivalent	B. Braun of America, Inc.
K980587	IV DECANTER-FLEXIBLE	Apr 17, 1998	Substantially Equivalent	Inrad
K980381	PHASEAL, CLOSED SYSTEM FORHANDLING OF PARENTERAL DRUGS, ADDITIONAL ADMINISTRATION DEVICES. C80 INFUSION ADAPTER, A10 PRO	Mar 03, 1998	Substantially Equivalent	Carmel Pharma Ab.
K974431	CHEMO-SPIKE II RECONSTITUTION DEVICE	Jan 08, 1998	Substantially Equivalent	Medi-Dose, Inc.
K974198	TAKY-SPIKE PLUS	Dec 22, 1997	Substantially Equivalent	Clinico
K973654	VIAL-MATE RECONSTITUTION DEVICE (2B8071)	Oct 24, 1997	Substantially Equivalent	Baxter Healthcare Corp
K961008	AUTOMIX 3+3/AS COMPOUNDER SYSTEM	Oct 10, 1997	Substantially Equivalent	Baxter Healthcare Corp
K972134	BAG DECANTER	Aug 26, 1997	Substantially Equivalent	Remington Medical, Inc.
K972117	MSI BOTTLEFLOW, TRANSFLOW, VIALFLOW	Aug 26, 1997	Substantially Equivalent	Medical Specialty Innovations, Inc. (Msi)
K955622	AUTOMIX PLUS, 3+3, MICROMIX COMPOUNDING SYSTEM;	May 06, 1997	Substantially Equivalent	Baxter Healthcare Corp
K970789	SAFE-CONNECT VIAL DISPENSING SPIKE	May 01, 1997	Substantially Equivalent	Faulding Medical Device Co.
K964989	CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5)	Apr 02, 1997	Substantially Equivalent	Critical Device Corp.
K970359	COMBIPROT EMERGENCY ENFUSION DEVICE	Mar 18, 1997	Substantially Equivalent	B.Braun Medical, Inc.
K963012	BIOJECT NEEDLE-FREE VIAL ADAPTER (13MM)	Oct 15, 1996	Substantially Equivalent	Bioject, Inc.
K963583	MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PREATTACHED NEEDLE	Oct 07, 1996	Substantially Equivalent	Medimop Medical Projects, Ltd.
K960466	IVEX-2 EXTENSION SET WITH Y-INJECTION SITE (MODIFICATION)	May 29, 1996	Substantially Equivalent	Abbott Laboratories
K960921	CODAN MEDLON BC110 VIAL ADAPTER CODAN SPIKE	Apr 17, 1996	Substantially Equivalent	Codan Medlon, Inc.
K955398	FORMULATION PREPARATION DEVICE	Apr 04, 1996	Substantially Equivalent	B.Braun Medical, Inc.
K955595	SAFELINE MULTIDOSE VIAL ADAPTER	Mar 06, 1996	Substantially Equivalent	Mcgaw, Inc.
K955594	SAFELINE I.V. BAG ACCESS DEVICE	Mar 06, 1996	Substantially Equivalent	Mcgaw, Inc.
K955896	MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-11	Feb 06, 1996	Substantially Equivalent	Critical Device Corp.
K950305	QTMICRO(TM) SYSTEM	Oct 13, 1995	Substantially Equivalent	Q.I. Medical, Inc.
K943095	IV TRANSFER SPIKE	Sep 30, 1994	Substantially Equivalent	Migada, Ltd.
K943181	DISPENSING PIN WITH ONE-WAY VALVE	Sep 29, 1994	Substantially Equivalent	B. Braun of America, Inc.
K935532	TRANSFER SET	Apr 04, 1994	Substantially Equivalent	Puritas Health Care, Inc.
K935274	DIPRIVAN LUER CONNECTOR	Mar 15, 1994	Substantially Equivalent	Ohmeda Medical
K926071	ONCO-VIAL ADAPTER	Feb 14, 1994	Substantially Equivalent	David Bull Laboratories, USA, Inc.
K932462	VENTED NEEDLE	Sep 15, 1993	Substantially Equivalent	Excel Medical, Inc.
K923782	TRANSFER SET	Jul 02, 1993	Substantially Equivalent	Pacific Device, Inc.
K923966	SYRINGE ADAPTOR	Jun 18, 1993	Substantially Equivalent	Excel Medical, Inc.
K924064	INTERLINK UNIVERSAL VIAL ADAPTER	Apr 21, 1993	Substantially Equivalent	Baxter Healthcare Corp
K925401	IV FLUID TRANSFER PIN	Mar 03, 1993	Substantially Equivalent	B. Braun of America, Inc.
K920015	QUICKTEST SYSTEM	Nov 23, 1992	Substantially Equivalent	Q.I. Medical, Inc.
K921031	EDGE MEDICAL DISPENSING PIN	Oct 19, 1992	Substantially Equivalent	Edgewater Medical Center
K921365	NUTRIMIX MICROCOMPOUNDER	Jun 30, 1992	Substantially Equivalent	Abbott Laboratories
K913985	TRANSFER-AID(TM)	Mar 18, 1992	Substantially Equivalent	Healthtek, Inc.
K912771	ACACIAS PHARM/PUMP	Feb 14, 1992	Substantially Equivalent	Acacia, Inc.
K913804	EXCELSIOR SINGLE LEAD DISPENSING SET	Feb 11, 1992	Substantially Equivalent	Excel Medical, Inc.
K902853	GRAVITY PLUS CONTROLLER/COMPOUNDER	May 09, 1991	Substantially Equivalent	Fergy Corp.
K905116	PHARM-ASSIST	Apr 25, 1991	Substantially Equivalent	Excel Medical, Inc.
K910213	NUTRIMIX(R) MACRO(TM) TPN COMPOUNDER/MODIFICATION	Apr 16, 1991	Substantially Equivalent	Abbott Laboratories
K910793	RECONSTITUTION DEVICE	Mar 21, 1991	Substantially Equivalent	Baxter Healthcare Corp
K905201	TPN FLUID TRANSFER SET	Jan 02, 1991	Substantially Equivalent	Mcgaw, Inc.
K904855	ADD-A-VIAL	Nov 19, 1990	Substantially Equivalent	Kendall Mcgaw Laboratories, Inc.
K903159	VALVE CONTROLLER FOR MICROMACRO COMPOUNDER	Nov 07, 1990	Substantially Equivalent	Baxa Corp., Sub. of Cook Group, Inc.
K904225	KWIKMIX	Nov 05, 1990	Substantially Equivalent	Baxa Corp., Sub. of Cook Group, Inc.
K895922	METRICARE EMPTY CONTAINER SYSTEMS	Aug 22, 1990	Substantially Equivalent	Metrix Co.
K900865	ADD-A-VIAL II BINARY CONNECTOR	Jul 11, 1990	Substantially Equivalent	Kendall Mcgaw Laboratories, Inc.
K901063	LUER LOCK TRANSFER PIN	Jul 06, 1990	Substantially Equivalent	Acacia, Inc.
K902482	VITALMIX (SET & BAG)	Jul 02, 1990	Substantially Equivalent	Pacific Device, Inc.
K901404	NUTRIMIX MACRO TPN COMPOUNDER	Jun 26, 1990	Substantially Equivalent	Abbott Laboratories
K900585	TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP	Apr 18, 1990	Substantially Equivalent	Baxa Corp., Sub. of Cook Group, Inc.
K896990	PHARMULATOR	Mar 23, 1990	Substantially Equivalent	Acacia, Inc.
K890205	AUTOMIX COMPOUNDER Y - ADAPTOR SET	Oct 27, 1989	Substantially Equivalent	Stedim, Inc.
K890204	AUTOMIX COMPOUNDER VENTED SPIKE ADAPTOR	Oct 27, 1989	Substantially Equivalent	Stedim, Inc.
K894827	AUTOMIX 3+3 COMPOUNDER	Oct 06, 1989	Substantially Equivalent	Baxter Healthcare Corp
K884626	MODIFIED SLIDING RECONSTITUTION DEVICE	Nov 22, 1988	Substantially Equivalent	Baxter Healthcare Corp
K874495	ADCOMP 4000 HP SYSTEM	Feb 16, 1988	Substantially Equivalent	Healthtek, Inc.
K872446	MODIFIED INSTAFIL	Aug 25, 1987	Substantially Equivalent	Instafil, Inc.
K860610	ADCOMP	Jul 08, 1986	Substantially Equivalent	Healthtek, Inc.
K860703	U - STAR (MICRO-STAR)	May 06, 1986	Substantially Equivalent	Corning Costar Corp.
K861434	MODIFIED HC-417 BAG TO BAG & HC-418 BOTTLE TO BAG	May 01, 1986	Substantially Equivalent	Churchill Corp.
K860595	TRANSFER SET	Apr 07, 1986	Substantially Equivalent	Migada, Ltd.
K860434	CHEMO-VENT	Feb 12, 1986	Substantially Equivalent	Intl. Medical Industries
K860113	DOUBLE-JECT TRANSFER NEEDLE	Feb 12, 1986	Substantially Equivalent	Medimix Products, Inc.
K854556	TRANSFER NEEDLE	Jan 16, 1986	Substantially Equivalent	Soma Intl., Inc.
K854008	STATLOCK	Nov 13, 1985	Substantially Equivalent	Healthtek, Inc.
K853830	SLIDING RECONSTITUTION DEVICE W/ADMIX VIALEX PLAST	Nov 06, 1985	Substantially Equivalent	Travenol Laboratories, S.A.
K852467	VIAL VENT FILTER	Oct 17, 1985	Substantially Equivalent	Baxter Healthcare Corp
K853075	MEDNOVA SAFETY BAG	Oct 16, 1985	Substantially Equivalent	Mednova Corp.
K853212	FLOW EASE(PLASTIC VENTED NEEDLE)	Sep 19, 1985	Substantially Equivalent	Acacia, Inc.
K853188	TRANSFER DEVICE	Aug 21, 1985	Substantially Equivalent	Advance Medical Designs, Inc.
K852882	MAXIFILL TRANSFER SET	Aug 16, 1985	Substantially Equivalent	Lyphomed, Inc.
K850757	TANDEM SETS I.V.	Apr 04, 1985	Substantially Equivalent	Acacia, Inc.
K850051	VERSA-FILL 120 & FILL SET 42-50	Mar 06, 1985	Substantially Equivalent	Intl. Medical Industries
K844904	CYTOSAFE NEEDLE	Feb 22, 1985	Substantially Equivalent	Baxa Corp., Sub. of Cook Group, Inc.
K843639	ADD-A-VIAL SOLUTION TRANSFER DEVICE	Jan 14, 1985	Substantially Equivalent	American Mcgaw
K844340	TRAVENOL RECONSTITUTION DEVICE W/ADMIX CAP	Jan 09, 1985	Substantially Equivalent	Travenol Laboratories, S.A.
K842345	MAXIFILL TRANSFER SET	Aug 17, 1984	Substantially Equivalent	Lyphomed, Inc.
K834500	SOLUTION TRANSFER SET	Feb 17, 1984	Substantially Equivalent	Berlex Laboratories, Inc.
K832347	TWOFER NEEDLE	Sep 12, 1983	Substantially Equivalent	Baxa Corp., Sub. of Cook Group, Inc.
K832332	VENTED I.V. TRANSFER NEEDLE	Sep 12, 1983	Substantially Equivalent	Baxa Corp., Sub. of Cook Group, Inc.
K832312	I.V. TRANSFER NEEDLE	Sep 12, 1983	Substantially Equivalent	Baxa Corp., Sub. of Cook Group, Inc.
K830836	Q.C. TESTER	Apr 18, 1983	Substantially Equivalent	Alltek Filtration, Inc.
K830970	DOUBLE LUMEN TRANSFER DEVICE	Apr 12, 1983	Substantially Equivalent	Codan Trading Co.
K820937	ACKRAD FLUID CONNECTING SET	Apr 26, 1982	Substantially Equivalent	Ackrad Laboratories
K812928	VACU-FIL TRANSFER SET	Dec 30, 1981	Substantially Equivalent	American Pharmaseal Div. Ahsc