Product Code: KPE FDA class 2 21 CFR 880.5025

Container, I.V.

General Hospital

This device is an intravenous (I.V.) container used to hold and deliver fluids, medications, or parenteral nutrition to patients via intravenous infusion. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KPE, regulated under 21 CFR 880.5025 within the General Hospital specialty. This device is eligible for third-party review as part of the 510(k) process.

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510(k)s

117

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: KPE
Device Class: FDA class 2
Regulation Number: 880.5025
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 117 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252079	Disposable Infusion Bag for Parenteral Nutrition	Apr 02, 2026	Substantially Equivalent	Beijing L&Z Medical Technology Development Co., Ltd.
K251980	ClaveQS Bag	Mar 20, 2026	Substantially Equivalent	Icu Medical, Inc.
K251139	KabiHelp® Uno; KabiHelp® Advance plus	Jan 09, 2026	Substantially Equivalent	Fresenius Kabi AG
K252094	eZSURE Empty Fluid Container	Aug 01, 2025	Substantially Equivalent	Epic Medical Pte. , Ltd.
K250459	DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution	Apr 18, 2025	Substantially Equivalent	Technoflex Sas.
K241442	eZSURE Empty Fluid Container with ProSeal Injection Site	Jun 21, 2024	Substantially Equivalent	Epic Medical Pte. , Ltd.
K223674	eZSURE Empty Fluid Container (models 426030, 426040, 426110)	Sep 01, 2023	Substantially Equivalent	Epic Medical Pte. , Ltd.
K222622	Disposable Infusion Bag for Parenteral Nutrition	Feb 16, 2023	Substantially Equivalent	Beijing L&Z Medical Technology Development Co., Ltd.
K210749	Empty EVA Bag	Aug 19, 2021	Substantially Equivalent	Haemotronic S.P.A.
K201936	SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL	May 06, 2021	Substantially Equivalent	Gilero, LLC
K193528	Empty EVA Bag	Jul 22, 2020	Substantially Equivalent	Haemotronic S.P.A.
K190328	HCT Empty EVA Container Pack	Aug 15, 2019	Substantially Equivalent	Health Care Technologies
K190305	Additive Cap	Apr 30, 2019	Substantially Equivalent	International Medical Industries, Inc.
K181393	Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP	Feb 15, 2019	Substantially Equivalent	Valmed S.R.L.
K132276	STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML	Nov 12, 2013	Substantially Equivalent	Hospira, Inc.
K121161	EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER	Jul 13, 2012	Substantially Equivalent	Acta Medical, LLC
K111217	ADDITIVE CAP	Jun 14, 2011	Substantially Equivalent	Baxter Healthcare Corp
K101412	EVA TPN BAG	Apr 13, 2011	Substantially Equivalent	Valmed S.R.L.
K090096	ALL-IN-ONE CONTAINER	Jan 30, 2009	Substantially Equivalent	Baxter Healthcare Corporation
K073538	DUAL CHAMBER TPN CONTAINER	Mar 12, 2008	Substantially Equivalent	B.Braun Medical, Inc.
K061197	KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER	Jun 30, 2006	Substantially Equivalent	Kawasumi Laboratories, Inc.
K041038	CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER	Dec 21, 2004	Substantially Equivalent	Churchill Medical Systems, Inc.
K041415	EVA TPN CONTAINER	Aug 04, 2004	Substantially Equivalent	B.Braun Medical, Inc.
K033916	GRI-BAG, GRI-BAG AP	Dec 30, 2003	Substantially Equivalent	Laboratorios Grifols, S.A.
K031419	GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML	Nov 24, 2003	Substantially Equivalent	Laboratorios Grifols, S.A.
K030888	EVA EMPTY SOLUTION CONTAINER	Apr 02, 2003	Substantially Equivalent	Metrix Co.
K020485	ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML	Mar 12, 2002	Substantially Equivalent	Baxter Healthcare Corp
K001461	TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET	Sep 11, 2000	Substantially Equivalent	Biometrix , Ltd.
K001287	EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML	Jun 09, 2000	Substantially Equivalent	Sorenson Medical, Inc.
K983294	ALL-IN-ONE CONTAINER CAT#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112, 2B8117M 2B8122, 2B8132, 2B8142, 2B712	Nov 03, 1998	Substantially Equivalent	Baxter Healthcare Corp
K982048	MPS RESERVOIR BAG	Jul 27, 1998	Substantially Equivalent	Medical Product Specialists
K974180	STERI-TAMP	Feb 24, 1998	Substantially Equivalent	Pharmacy, Inc.
K973103	CHARTERMED TPN-EVA BAGS	Nov 24, 1997	Substantially Equivalent	Chartermed, Inc.
K972464	VITALMIX PLUS EMPTY I.V. CONTAINER	Nov 05, 1997	Substantially Equivalent	Pacific Device, Inc.
K964853	INTRAVIA CONTAINER, EMPTY	Mar 31, 1997	Substantially Equivalent	Baxter Healthcare Corp
K960581	SECURE EVA DUAL CHAMBER MIXING BAG	Apr 30, 1996	Substantially Equivalent	Secure Medical Products, Inc.
K945193	ALL-IN-ONE TWO CHAMBER CONTAINER	May 12, 1995	Substantially Equivalent	Baxter Healthcare Corp
K941731	EMPTY, SOLUTION TRANSFER CONTAINER WITH DETATCHABLE LEG SET	Jul 22, 1994	Substantially Equivalent	Incutech, Inc.
K932477	UNIMIX CONAINER-EMPTY CONTAINER W/3 LEAD TRANS.SET	Jun 10, 1994	Substantially Equivalent	Baxter Healthcare Corp
K934179	DISPOSABLE BAG DECANTER	May 23, 1994	Substantially Equivalent	Byron Medical
K940258	SOLUTION TRANSFER CONTAINER W/ATTACHED LEG SET (EMPTY)	Mar 28, 1994	Substantially Equivalent	Incutech, Inc.
K932649	PHARMAFEED	Nov 16, 1993	Substantially Equivalent	Plasco, Inc.
K932641	EMPTY MIXING CONTAINER	Nov 10, 1993	Substantially Equivalent	Douglas Medical Products Corp.
K932640	EVA EMPTY MIXING CONTAINER	Nov 10, 1993	Substantially Equivalent	Douglas Medical Products Corp.
K926123	DUAL CHAMBER MIXING BAG	Sep 03, 1993	Substantially Equivalent	Secure Medical, Inc.
K923448	EMPTY SOLUTION TRANSFER CONTAINER W/ DETACH LEG	Jul 28, 1993	Substantially Equivalent	Healthtek, Inc.
K922214	EMPTY VIAFLEX PLASTIC CONTAINER	Mar 26, 1993	Substantially Equivalent	Baxter Healthcare Corp
K913608	SNAPPER	Nov 29, 1991	Substantially Equivalent	Healthtek, Inc.
K911567	DUAL COMPARTMENT TPN BAG 3 LITER	Aug 02, 1991	Substantially Equivalent	Stedim, Inc.
K910936	EMPTY I.V. CONTAINER	Jul 16, 1991	Substantially Equivalent	Ellis Pharmaceutical Consulting, Inc.
K911576	CHEMOTHERAPY CONTAINER	Jul 05, 1991	Substantially Equivalent	Bemis Mfg. Co.
K910673	BAG SPIGOT	Apr 24, 1991	Substantially Equivalent	Procedure Products, Inc.
K902079	ADMIXTURE CONTAINER FOR TOTAL PARENTERAL NUTRITION	Oct 29, 1990	Substantially Equivalent	Chartermed, Inc.
K902464	CHARTERMED EMPTY TPN CONTAINER - 100 ML CAPACITY	Aug 30, 1990	Substantially Equivalent	Chartermed, Inc.
K895924	METRICARE DRUG RESERVOIRS	Jul 26, 1990	Substantially Equivalent	Metrix Co.
K883400	OPTUM(TM) AUTOMATED PATIENT ASSIST DEVICE	Dec 01, 1989	Substantially Equivalent	Abbott Laboratories
K885173	MIX CONTAINER W/ATTACHED TRANSFER SET	Jun 07, 1989	Substantially Equivalent	Medical Support Systems
K891077	MEDIVERSE PARENTERAL NUTRITION BAG	May 24, 1989	Substantially Equivalent	Mediflex Intl.
K890095	PVC EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET	May 24, 1989	Substantially Equivalent	Kells Medical, Inc.
K890094	EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET	May 24, 1989	Substantially Equivalent	Kells Medical, Inc.
K890268	PRESSURE INFUSOR FOR I.V. BAGS/AUTOINFLATION	May 05, 1989	Substantially Equivalent	Biomedical Dynamics, Inc.
K890272	BAG DECANTER	Mar 14, 1989	Substantially Equivalent	Superior Medical Products
K880506	MODIFIED EVA-MIX AND DI-MIX BAGS	May 20, 1988	Substantially Equivalent	Gil-Med Industries C/O Kegan & Kegan, Ltd.
K875155	60 ML RESERVOIR BAG, ITEM #200	Feb 16, 1988	Substantially Equivalent	Prn Services, Inc.
K870395	CHURCHILL PARENTERAL NUTRITION BAG - EVA	Oct 15, 1987	Substantially Equivalent	Churchill Corp.
K871449	ONCOLOGY SPT SYS #MS-C10 MEDICATION RESERVOIR BAG	Jun 17, 1987	Substantially Equivalent	Pa Medical Corp.
K870052	INFUMIX MIXING CONTAINER	Feb 27, 1987	Substantially Equivalent	Biodynamics Corp.
K870113	THERMAL JACKET FOR I.V. FLUID BAGS	Feb 25, 1987	Substantially Equivalent	Thermal Medical Systems, Inc.
K870274	DI-MIX PARENTERAL NUTRITION & MEDICINE CONTAINER	Feb 10, 1987	Substantially Equivalent	Gil-Med Industries C/O Kegan & Kegan, Ltd.
K863040	DISPOSABLE INTRAVENOUS HYPERALIMENTATION BAGS	Oct 31, 1986	Substantially Equivalent	Cher Mel Corp.
K860042	NUTRIMIX EMPTY CONTAINER	Apr 09, 1986	Substantially Equivalent	Abbott Laboratories
K854034	SNAP-LOCK ADDITIVE CAP #SL 300	Nov 06, 1985	Substantially Equivalent	Williams Medical Co.
K854033	SNAP-LOCK ADDITIVE CAP #SL400	Nov 06, 1985	Substantially Equivalent	Williams Medical Co.
K854031	SNAP-LOCK ADDITIVE CAP #SL100	Nov 06, 1985	Substantially Equivalent	Williams Medical Co.
K854032	SNAP-LOCK ADDITIVE CAP #SL 200	Nov 01, 1985	Substantially Equivalent	Williams Medical Co.
K852938	TUF TRACK MODEL TT83 CUBICLE TRACK & IV83 INTR TRK	Sep 30, 1985	Substantially Equivalent	Northern Customfab, Inc.
K852893	VIAL DECANTER	Sep 20, 1985	Substantially Equivalent	Advance Medical Designs, Inc.
K852778	BOTTLE DECANTER	Aug 16, 1985	Substantially Equivalent	Advance Medical Designs, Inc.
K852777	BAG DECANTER	Aug 16, 1985	Substantially Equivalent	Advance Medical Designs, Inc.
K850035	EMPTY SOLUTION TRANSFER CONTAINER	Jun 07, 1985	Substantially Equivalent	The Healthcare Group Laboratories, Inc.
K844664	THE I.V. BAG	May 06, 1985	Substantially Equivalent	Kabivitrum, Inc.
K844077	NUTRIMIX EMPTY CONTAINER	Feb 15, 1985	Substantially Equivalent	Abbott Laboratories
K844410	NUTRIBAG MIXING CONTAINER -2000 ML	Nov 28, 1984	Substantially Equivalent	Medical & Pharmaceutical Supplies, Inc.
K843954	MIXING CONTAINER	Nov 28, 1984	Substantially Equivalent	American Mcgaw
K841597	GIL-MED PARENTERAL NUTRITION OR MEDICINE	Oct 26, 1984	Substantially Equivalent	Gil-Med Industries C/O Kegan & Kegan, Ltd.
K842170	EMPTY SOLUTION TRANSFER CONTAINER	Oct 19, 1984	Substantially Equivalent	The Healthcare Group Laboratories, Inc.
K843523	EMPTY SOLUTION TRANSFER CONTAINER 1000	Oct 16, 1984	Substantially Equivalent	Polymer Technology Corp.
K842629	HOME NUTRIBAG MIXING CONTAINER 3000ML	Sep 07, 1984	Substantially Equivalent	Medical & Pharmaceutical Supplies, Inc.
K842628	HOME NUTRIBAG MIXING CONTAINER 1000ML	Sep 07, 1984	Substantially Equivalent	Medical & Pharmaceutical Supplies, Inc.
K840915	DIMIX CONTAINER FOR PARNETERAL NUTRIT	Apr 17, 1984	Substantially Equivalent	Gil-Med Industries C/O Kegan & Kegan, Ltd.
K840388	PAB IV CONTAINER	Mar 06, 1984	Substantially Equivalent	American Mcgaw
K832254	BAXA ADDISEAL	Jul 26, 1983	Substantially Equivalent	Baxa Corp., Sub. of Cook Group, Inc.
K832247	I.V. BAG ADDISEAL	Jul 26, 1983	Substantially Equivalent	Baxa Corp., Sub. of Cook Group, Inc.
K830193	CAT 3040	Mar 09, 1983	Substantially Equivalent	Burron Medical Products, Inc.
K830450	DELMED IV CONTAINER	Mar 01, 1983	Substantially Equivalent	Delmed, Inc.
K830299	SOLUTION TRANSFER CONTAINER	Feb 19, 1983	Substantially Equivalent	The Healthcare Group Laboratories, Inc.
K830232	DECANTER MODELS-VARIOUS	Feb 09, 1983	Substantially Equivalent	Steri-Sytems, Corp.
K823538	POUR BOTTLE DECANTER #2010	Jan 26, 1983	Substantially Equivalent	Medi-Plant Intl.
K820200	IV ALERT SYSTEM	Mar 18, 1982	Substantially Equivalent	Allied Medical Technologies, Inc.
K820435	BAXA ADDISEAL	Mar 08, 1982	Substantially Equivalent	Baxa Corp., Sub. of Cook Group, Inc.
K813435	BAXA ADLI SEAL	Dec 18, 1981	Substantially Equivalent	Baxa Corp., Sub. of Cook Group, Inc.
K812852	SET FOR ASEPTIC DECANTING OF A FLEX I.V	Nov 02, 1981	Substantially Equivalent	Dip, Inc.
K812527	IVA SEAL II	Sep 16, 1981	Substantially Equivalent	U.S. Clinical Products, Inc.
K811268	BOTTLE-TO-BOTTLE	Jun 18, 1981	Substantially Equivalent	Medi-Plast Intl., Inc.
K811234	I.V. BOTTLE (RIDGID)	Jun 18, 1981	Substantially Equivalent	Medi-Plast Intl., Inc.
K811233	I.V. PLASTIC BAG	Jun 17, 1981	Substantially Equivalent	Medi-Plast Intl., Inc.
K811269	GLASS VIALS	Jun 16, 1981	Substantially Equivalent	Medi-Plast Intl., Inc.
K810795	INSTAFIL	Jun 12, 1981	Substantially Equivalent	Instafil, Inc.
K802966	I.V. ADDITIVE CAP	Jan 07, 1981	Substantially Equivalent	Baxa Corp., Sub. of Cook Group, Inc.
K801652	TOTAL PARENTERAL NUTRITION SET BAG	Aug 27, 1980	Substantially Equivalent	Cutter Laboratories, Inc.
K791774	LIFE CARE 1000ML.EMP. CONT. W/AT. Y-TRAN	Oct 26, 1979	Substantially Equivalent	Abbott Laboratories
K791796	ADDITIVE HINGE CAP	Oct 01, 1979	Substantially Equivalent	Abbott Laboratories
K782113	CAP, TAMPER PROOF PLASTIC	Jun 01, 1979	Substantially Equivalent	Acacia, Inc.
K771432	HICALIQ IVH BAG	Sep 28, 1977	Substantially Equivalent	Terumo America, Inc.
K771121	EMPTY ADMIXTURE CONTAINERS	Aug 03, 1977	Substantially Equivalent	Medi, Inc.
K771228	LIFECARE EMPTY CONTAINER	Aug 02, 1977	Substantially Equivalent	Abbott Laboratories
K760880	ADDITIVE CAP (2B8905)	Dec 30, 1976	Substantially Equivalent	Travenol Laboratories, S.A.