Product Code: MRZ FDA class 2 21 CFR 880.5725

Accessories, Pump, Infusion

General Hospital

Accessories for Infusion Pumps are supplementary components designed to support the operation of infusion pump systems used in clinical settings for the controlled delivery of fluids, medications, or nutrients to patients. These accessories fall under FDA Class 2 (510(k)), meaning manufacturers must demonstrate substantial equivalence to a predicate device before marketing. The product code is MRZ, regulated under 21 CFR 880.5725, and overseen by the General Hospital medical specialty panel. This device is not classified as an implant and does not have life-sustaining or life-supporting designation.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: MRZ
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

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 48 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K230718	UTC 3mL Medication Cartridge	Jun 15, 2023	Substantially Equivalent	Gilero, LLC
K220695	Elite Biomedical Solutions Dose Request Cord	Apr 29, 2022	Substantially Equivalent	Elite Biomedical Solutions
K201634	RG 3ml Medication Cartridge	Mar 26, 2021	Substantially Equivalent	Chengdu Shifeng Medical Technology Co., Ltd.
K193654	BlueStar Rx	Apr 07, 2020	Substantially Equivalent	Welldoc, Inc.
K191910	SpaceStation MRI	Mar 12, 2020	Substantially Equivalent	B. Braun Melsugen AG
K190013	WellDoc BlueStar	Nov 04, 2019	Substantially Equivalent	Welldoc, Inc.
K173531	Lockbox for Perfusor Space PCA Infusion Pump	Aug 02, 2018	Substantially Equivalent	B.Braun Medical, Inc.
K171346	Sapphire Sets	Aug 25, 2017	Substantially Equivalent	Icu Medical
K162532	WellDoc BlueStar, WellDoc BlueStar Rx	Jan 12, 2017	Substantially Equivalent	Welldoc, Inc.
K160492	Hospira Sapphire Sets	Dec 06, 2016	Substantially Equivalent	Hospira, Inc.
K162225	WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System	Nov 22, 2016	Substantially Equivalent	Welldoc, Inc.
K142374	ivWatch Model 400	Feb 13, 2015	Substantially Equivalent	Ivwatch, LLC
K142333	SMART LABEL, PROPOFOL	Dec 18, 2014	Substantially Equivalent	American I.V. Products, Inc. Dba Aiv, Inc.
K141273	WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE	Jul 08, 2014	Substantially Equivalent	Welldoc, Inc.
K132618	ONETOUCH REVEAL	Dec 16, 2013	Substantially Equivalent	Lifescan, Inc.
K120209	PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE	Apr 12, 2012	Substantially Equivalent	American I.V. Products, Inc.
K120314	WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM	Feb 24, 2012	Substantially Equivalent	Welldoc, Inc.
K112370	WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM	Oct 14, 2011	Substantially Equivalent	Welldoc, Inc.
K101806	AIDERA DIASEND SYSTEM	Dec 07, 2010	Substantially Equivalent	Aidera AB
K100066	DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1	Jul 15, 2010	Substantially Equivalent	Welldoc, Inc.
K091181	LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPS	Jun 12, 2009	Substantially Equivalent	Smiths Medical MD, Inc.
K083221	AIDERA DIASEND	Feb 03, 2009	Substantially Equivalent	Aidera AB
K082783	CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CARE	Dec 17, 2008	Substantially Equivalent	Smiths Medical MD, Inc.
K080587	EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE	May 15, 2008	Substantially Equivalent	Animas Corp.
K080227	ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM	May 15, 2008	Substantially Equivalent	Roche Diagnostics Corp.
K072955	CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE-ADMINISTRATOR (21-6275), POINT OF CARE (21-6276)	Feb 13, 2008	Substantially Equivalent	Smiths Medical MD, Inc.
K070438	MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305	Oct 17, 2007	Substantially Equivalent	Medtronic Minimed, Inc.
K071418	DANA 3CC SYRINGE INSULIN RESERVOIR	Sep 04, 2007	Substantially Equivalent	Sooil Development Co., Ltd.
K051079	HOSPIRA GEMSTAR INFUSION PUMP SYSTEM WITH HOSPIRA GEMSTAR SPRING ASSIST MECHANISM LOCKBOX-7 THERAPY	May 19, 2005	Substantially Equivalent	Hospicare, Inc.
K030936	RITA CLIPS FOR INFUSION PUMPS	Apr 01, 2003	Substantially Equivalent	Rita Medical Systems, Inc.
K023890	PREPARE CARTRIDGE	Feb 07, 2003	Substantially Equivalent	Appro Healthcare, Inc.
K021974	MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL 7311	Aug 06, 2002	Substantially Equivalent	Minimed, Inc.
K012266	SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2	Sep 12, 2001	Substantially Equivalent	National Custom Ent., Inc.
K012262	BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC	Sep 12, 2001	Substantially Equivalent	National Custom Ent., Inc.
K012259	MEDFUSION 2001 & 2010, MODEL N7215IWC	Sep 12, 2001	Substantially Equivalent	National Custom Ent., Inc.
K990091	S.P.A.R STERILE AMBULATORY RESERVOIR	Apr 04, 1999	Substantially Equivalent	Faulding Pharmaceutical Co.
K980165	INFUTEST 2000 INFUSION DEVICE ANALYZER	Apr 20, 1998	Substantially Equivalent	Datrend Systems, Inc.
K961486	IVAC MEDSYSTEM III, INFUSION PUMP W/DRUG EDITING SOFTWARE KIT	Apr 17, 1998	Substantially Equivalent	Ivac Medical Systems
K970678	THE HARVARD LIBRARY	Jan 09, 1998	Substantially Equivalent	Harvard Apparatus, Inc.
K972780	ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625	Oct 20, 1997	Substantially Equivalent	Alexander Mfg. Co.
K972779	ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS3030-P	Oct 20, 1997	Substantially Equivalent	Alexander Mfg. Co.
K962159	STERILE AMBULATORY RESERVOIR 60ML/100ML	Jul 18, 1997	Substantially Equivalent	Faulding Medical Device Co.
K972089	ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS06224	Jul 03, 1997	Substantially Equivalent	Alexander Mfg. Co.
K971237	ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL8108	May 27, 1997	Substantially Equivalent	Alexander Mfg. Co.
K971234	ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL825	May 27, 1997	Substantially Equivalent	Alexander Mfg. Co.
K971213	ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY # GL825-P	May 27, 1997	Substantially Equivalent	Alexander Mfg. Co.
K971212	ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL4018	May 27, 1997	Substantially Equivalent	Alexander Mfg. Co.
K970786	ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M7)	May 27, 1997	Substantially Equivalent	Alexander Mfg. Co.