Atlas FDA

KPE

117 FDA 510(k) clearances · Product code

73 daysmedian time to decision
268 days90th percentile
117clearances measured

FDA profile

Official device name
Container, I.V.
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5025
Medical specialty
General Hospital
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 162 · 2022: 112 · 2023: 127 · 2024: 158 · 2025: 225 · 2026: 180
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Disposable Infusion Bag for Parenteral Nutrition (K252079)Beijing L&Z Medical Technology Development Co., Ltd.2026-04-02
ClaveQS™ Bag (K251980)Icu Medical, Inc.2026-03-20
KabiHelp® Uno; KabiHelp® Advance plus (K251139)Fresenius Kabi AG2026-01-09
eZSURE™ Empty Fluid Container (K252094)Epic Medical Pte. , Ltd.2025-08-01
DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution (K250459)Technoflex Sas.2025-04-18
eZSURE™ Empty Fluid Container with ProSeal™ Injection Site (K241442)Epic Medical Pte. , Ltd.2024-06-21
eZSURE™ Empty Fluid Container (models 426030, 426040, 426110) (K223674)Epic Medical Pte. , Ltd.2023-09-01
Disposable Infusion Bag for Parenteral Nutrition (K222622)Beijing L&Z Medical Technology Development Co., Ltd.2023-02-16
Empty EVA Bag (K210749)Haemotronic S.P.A.2021-08-19
SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL (K201936)Gilero, LLC2021-05-06
Empty EVA Bag (K193528)Haemotronic S.P.A.2020-07-22
HCT Empty EVA Container Pack (K190328)Health Care Technologies2019-08-15
Additive Cap (K190305)International Medical Industries, Inc.2019-04-30
Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP (K181393)Valmed S.R.L.2019-02-15
STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML (K132276)Hospira, Inc.2013-11-12
EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER (K121161)Acta Medical, LLC2012-07-13
ADDITIVE CAP (K111217)Baxter Healthcare Corp2011-06-14
EVA TPN BAG (K101412)Valmed S.R.L.2011-04-13
ALL-IN-ONE CONTAINER (K090096)Baxter Healthcare Corporation2009-01-30
DUAL CHAMBER TPN CONTAINER (K073538)B.Braun Medical, Inc.2008-03-12
KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER (K061197)Kawasumi Laboratories, Inc.2006-06-30
CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER (K041038)Churchill Medical Systems, Inc.2004-12-21
EVA TPN CONTAINER (K041415)B.Braun Medical, Inc.2004-08-04
GRI-BAG, GRI-BAG AP (K033916)Laboratorios Grifols, S.A.2003-12-30
GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML (K031419)Laboratorios Grifols, S.A.2003-11-24
EVA EMPTY SOLUTION CONTAINER (K030888)Metrix Co.2003-04-02
ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML (K020485)Baxter Healthcare Corp2002-03-12
TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET (K001461)Biometrix , Ltd.2000-09-11
EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML (K001287)Sorenson Medical, Inc.2000-06-09
ALL-IN-ONE CONTAINER CAT#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112, 2B8117M 2B8122, 2B8132, 2B8142, 2B712 (K983294)Baxter Healthcare Corp1998-11-03
MPS RESERVOIR BAG (K982048)Medical Product Specialists1998-07-27
STERI-TAMP (K974180)Pharmacy, Inc.1998-02-24
CHARTERMED TPN-EVA BAGS (K973103)Chartermed, Inc.1997-11-24
VITALMIX PLUS EMPTY I.V. CONTAINER (K972464)Pacific Device, Inc.1997-11-05
INTRAVIA CONTAINER, EMPTY (K964853)Baxter Healthcare Corp1997-03-31
SECURE EVA DUAL CHAMBER MIXING BAG (K960581)Secure Medical Products, Inc.1996-04-30
ALL-IN-ONE TWO CHAMBER CONTAINER (K945193)Baxter Healthcare Corp1995-05-12
EMPTY, SOLUTION TRANSFER CONTAINER WITH DETATCHABLE LEG SET (K941731)Incutech, Inc.1994-07-22
UNIMIX CONAINER-EMPTY CONTAINER W/3 LEAD TRANS.SET (K932477)Baxter Healthcare Corp1994-06-10
DISPOSABLE BAG DECANTER (K934179)Byron Medical1994-05-23
SOLUTION TRANSFER CONTAINER W/ATTACHED LEG SET (EMPTY) (K940258)Incutech, Inc.1994-03-28
PHARMAFEED (K932649)Plasco, Inc.1993-11-16
EVA EMPTY MIXING CONTAINER (K932640)Douglas Medical Products Corp.1993-11-10
EMPTY MIXING CONTAINER (K932641)Douglas Medical Products Corp.1993-11-10
DUAL CHAMBER MIXING BAG (K926123)Secure Medical, Inc.1993-09-03
EMPTY SOLUTION TRANSFER CONTAINER W/ DETACH LEG (K923448)Healthtek, Inc.1993-07-28
EMPTY VIAFLEX PLASTIC CONTAINER (K922214)Baxter Healthcare Corp1993-03-26
SNAPPER (K913608)Healthtek, Inc.1991-11-29
DUAL COMPARTMENT TPN BAG 3 LITER (K911567)Stedim, Inc.1991-08-02
EMPTY I.V. CONTAINER (K910936)Ellis Pharmaceutical Consulting, Inc.1991-07-16
CHEMOTHERAPY CONTAINER (K911576)Bemis Mfg. Co.1991-07-05
BAG SPIGOT (K910673)Procedure Products, Inc.1991-04-24
ADMIXTURE CONTAINER FOR TOTAL PARENTERAL NUTRITION (K902079)Chartermed, Inc.1990-10-29
CHARTERMED EMPTY TPN CONTAINER - 100 ML CAPACITY (K902464)Chartermed, Inc.1990-08-30
METRICARE DRUG RESERVOIRS (K895924)Metrix Co.1990-07-26
OPTUM(TM) AUTOMATED PATIENT ASSIST DEVICE (K883400)Abbott Laboratories1989-12-01
MIX CONTAINER W/ATTACHED TRANSFER SET (K885173)Medical Support Systems1989-06-07
PVC EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET (K890095)Kells Medical, Inc.1989-05-24
MEDIVERSE PARENTERAL NUTRITION BAG (K891077)Mediflex Intl.1989-05-24
EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET (K890094)Kells Medical, Inc.1989-05-24
PRESSURE INFUSOR FOR I.V. BAGS/AUTOINFLATION (K890268)Biomedical Dynamics, Inc.1989-05-05
BAG DECANTER (K890272)Superior Medical Products1989-03-14
MODIFIED EVA-MIX AND DI-MIX BAGS (K880506)Gil-Med Industries C/O Kegan & Kegan, Ltd.1988-05-20
60 ML RESERVOIR BAG, ITEM #200 (K875155)Prn Services, Inc.1988-02-16
CHURCHILL PARENTERAL NUTRITION BAG - EVA (K870395)Churchill Corp.1987-10-15
ONCOLOGY SPT SYS #MS-C10 MEDICATION RESERVOIR BAG (K871449)Pa Medical Corp.1987-06-17
INFUMIX MIXING CONTAINER (K870052)Biodynamics Corp.1987-02-27
THERMAL JACKET FOR I.V. FLUID BAGS (K870113)Thermal Medical Systems, Inc.1987-02-25
DI-MIX PARENTERAL NUTRITION & MEDICINE CONTAINER (K870274)Gil-Med Industries C/O Kegan & Kegan, Ltd.1987-02-10
DISPOSABLE INTRAVENOUS HYPERALIMENTATION BAGS (K863040)Cher Mel Corp.1986-10-31
NUTRIMIX EMPTY CONTAINER (K860042)Abbott Laboratories1986-04-09
SNAP-LOCK ADDITIVE CAP #SL100 (K854031)Williams Medical Co.1985-11-06
SNAP-LOCK ADDITIVE CAP #SL400 (K854033)Williams Medical Co.1985-11-06
SNAP-LOCK ADDITIVE CAP #SL 300 (K854034)Williams Medical Co.1985-11-06
SNAP-LOCK ADDITIVE CAP #SL 200 (K854032)Williams Medical Co.1985-11-01
TUF TRACK MODEL TT83 CUBICLE TRACK & IV83 INTR TRK (K852938)Northern Customfab, Inc.1985-09-30
VIAL DECANTER (K852893)Advance Medical Designs, Inc.1985-09-20
BAG DECANTER (K852777)Advance Medical Designs, Inc.1985-08-16
BOTTLE DECANTER (K852778)Advance Medical Designs, Inc.1985-08-16
EMPTY SOLUTION TRANSFER CONTAINER (K850035)The Healthcare Group Laboratories, Inc.1985-06-07
THE I.V. BAG (K844664)Kabivitrum, Inc.1985-05-06
NUTRIMIX EMPTY CONTAINER (K844077)Abbott Laboratories1985-02-15
MIXING CONTAINER (K843954)American Mcgaw1984-11-28
NUTRIBAG MIXING CONTAINER -2000 ML (K844410)Medical & Pharmaceutical Supplies, Inc.1984-11-28
GIL-MED PARENTERAL NUTRITION OR MEDICINE (K841597)Gil-Med Industries C/O Kegan & Kegan, Ltd.1984-10-26
EMPTY SOLUTION TRANSFER CONTAINER (K842170)The Healthcare Group Laboratories, Inc.1984-10-19
EMPTY SOLUTION TRANSFER CONTAINER 1000 (K843523)Polymer Technology Corp.1984-10-16
HOME NUTRIBAG MIXING CONTAINER 1000ML (K842628)Medical & Pharmaceutical Supplies, Inc.1984-09-07
HOME NUTRIBAG MIXING CONTAINER 3000ML (K842629)Medical & Pharmaceutical Supplies, Inc.1984-09-07
DIMIX CONTAINER FOR PARNETERAL NUTRIT (K840915)Gil-Med Industries C/O Kegan & Kegan, Ltd.1984-04-17
PAB IV CONTAINER (K840388)American Mcgaw1984-03-06
I.V. BAG ADDISEAL (K832247)Baxa Corp., Sub. of Cook Group, Inc.1983-07-26
BAXA ADDISEAL (K832254)Baxa Corp., Sub. of Cook Group, Inc.1983-07-26
CAT 3040 (K830193)Burron Medical Products, Inc.1983-03-09
DELMED IV CONTAINER (K830450)Delmed, Inc.1983-03-01
SOLUTION TRANSFER CONTAINER (K830299)The Healthcare Group Laboratories, Inc.1983-02-19
DECANTER MODELS-VARIOUS (K830232)Steri-Sytems, Corp.1983-02-09
POUR BOTTLE DECANTER #2010 (K823538)Medi-Plant Intl.1983-01-26
IV ALERT SYSTEM (K820200)Allied Medical Technologies, Inc.1982-03-18
BAXA ADDISEAL (K820435)Baxa Corp., Sub. of Cook Group, Inc.1982-03-08
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Every clearance here is in the API, with alerts when new ones post.