Panels › General Hospital › Product code KPE · Class 2
Container, I.V.
Regulation 880.5025
3510(k)s in 12 months (117 all time)
0recalls in 12 months (62 all time)
57recalls that name a 510(k)
Top companies in KPE
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 2, 2026 | K252079 | Disposable Infusion Bag for Parenteral Nutrition Beijing L&Z Medical Technology Development Co., Ltd., CN | KPE |
| Mar 20, 2026 | K251980 | ClaveQS Bag Icu Medical, Inc. | KPE |
| Jan 9, 2026 | K251139 | KabiHelp® Uno; KabiHelp® Advance plus Fresenius Kabi AG, DE | KPE |
| Aug 1, 2025 | K252094 | eZSURE Empty Fluid Container Epic Medical Pte. , Ltd., SG | KPE |
| Apr 18, 2025 | K250459 | DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000 Technoflex Sas., FR | KPE |
| Jun 21, 2024 | K241442 | eZSURE Empty Fluid Container with ProSeal Injection Site Epic Medical Pte. , Ltd., SG | KPE |
| Sep 1, 2023 | K223674 | eZSURE Empty Fluid Container (models 426030, 426040, 426110) Epic Medical Pte. , Ltd., SG | KPE |
| Feb 16, 2023 | K222622 | Disposable Infusion Bag for Parenteral Nutrition Beijing L&Z Medical Technology Development Co., Ltd., CN | KPE |
| Aug 19, 2021 | K210749 | Empty EVA Bag Haemotronic S.P.A., IT | KPE |
| May 6, 2021 | K201936 | SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL Gilero, LLC | KPE |
| Jul 22, 2020 | K193528 | Empty EVA Bag Haemotronic S.P.A., IT | KPE |
| Aug 15, 2019 | K190328 | HCT Empty EVA Container Pack Health Care Technologies | KPE |
| Apr 30, 2019 | K190305 | Additive Cap International Medical Industries, Inc. | KPE |
| Feb 15, 2019 | K181393 | Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP Valmed S.R.L., IT | KPE |
| Nov 12, 2013 | K132276 | STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML Hospira, Inc. | KPE |
| Jul 13, 2012 | K121161 | EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER Acta Medical, LLC | KPE |
| Jun 14, 2011 | K111217 | ADDITIVE CAP Baxter Healthcare Corp | KPE |
| Apr 13, 2011 | K101412 | EVA TPN BAG Valmed S.R.L., IT | KPE |
| Jan 30, 2009 | K090096 | ALL-IN-ONE CONTAINER Baxter Healthcare Corporation | KPE |
| Mar 12, 2008 | K073538 | DUAL CHAMBER TPN CONTAINER B.Braun Medical, Inc. | KPE |
| Jun 30, 2006 | K061197 | KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER Kawasumi Laboratories, Inc. | KPE |
| Dec 21, 2004 | K041038 | CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER Churchill Medical Systems, Inc. | KPE |
| Aug 4, 2004 | K041415 | EVA TPN CONTAINER B.Braun Medical, Inc. | KPE |
| Dec 30, 2003 | K033916 | GRI-BAG, GRI-BAG AP Laboratorios Grifols, S.A., ES | KPE |
| Nov 24, 2003 | K031419 | GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML Laboratorios Grifols, S.A., ES | KPE |
| Apr 2, 2003 | K030888 | EVA EMPTY SOLUTION CONTAINER Metrix Co. | KPE |
| Mar 12, 2002 | K020485 | ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML Baxter Healthcare Corp | KPE |
| Sep 11, 2000 | K001461 | TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET Biometrix , Ltd., IL | KPE |
| Jun 9, 2000 | K001287 | EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML Sorenson Medical, Inc. | KPE |
| Nov 3, 1998 | K983294 | ALL-IN-ONE CONTAINER CAT#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112, 2B8117M 2B8122, 2B8132, 2B8142, 2B712 Baxter Healthcare Corp | KPE |
| Jul 27, 1998 | K982048 | MPS RESERVOIR BAG Medical Product Specialists | KPE |
| Feb 24, 1998 | K974180 | STERI-TAMP Pharmacy, Inc. | KPE |
| Nov 24, 1997 | K973103 | CHARTERMED TPN-EVA BAGS Chartermed, Inc. | KPE |
| Nov 5, 1997 | K972464 | VITALMIX PLUS EMPTY I.V. CONTAINER Pacific Device, Inc. | KPE |
| Mar 31, 1997 | K964853 | INTRAVIA CONTAINER, EMPTY Baxter Healthcare Corp | KPE |
| Apr 30, 1996 | K960581 | SECURE EVA DUAL CHAMBER MIXING BAG Secure Medical Products, Inc. | KPE |
| May 12, 1995 | K945193 | ALL-IN-ONE TWO CHAMBER CONTAINER Baxter Healthcare Corp | KPE |
| Jul 22, 1994 | K941731 | EMPTY, SOLUTION TRANSFER CONTAINER WITH DETATCHABLE LEG SET Incutech, Inc. | KPE |
| Jun 10, 1994 | K932477 | UNIMIX CONAINER-EMPTY CONTAINER W/3 LEAD TRANS.SET Baxter Healthcare Corp | KPE |
| May 23, 1994 | K934179 | DISPOSABLE BAG DECANTER Byron Medical | KPE |
| Mar 28, 1994 | K940258 | SOLUTION TRANSFER CONTAINER W/ATTACHED LEG SET (EMPTY) Incutech, Inc. | KPE |
| Nov 16, 1993 | K932649 | PHARMAFEED Plasco, Inc. | KPE |
| Nov 10, 1993 | K932641 | EMPTY MIXING CONTAINER Douglas Medical Products Corp. | KPE |
| Nov 10, 1993 | K932640 | EVA EMPTY MIXING CONTAINER Douglas Medical Products Corp. | KPE |
| Sep 3, 1993 | K926123 | DUAL CHAMBER MIXING BAG Secure Medical, Inc. | KPE |
| Jul 28, 1993 | K923448 | EMPTY SOLUTION TRANSFER CONTAINER W/ DETACH LEG Healthtek, Inc. | KPE |
| Mar 26, 1993 | K922214 | EMPTY VIAFLEX PLASTIC CONTAINER Baxter Healthcare Corp | KPE |
| Nov 29, 1991 | K913608 | SNAPPER Healthtek, Inc. | KPE |
| Aug 2, 1991 | K911567 | DUAL COMPARTMENT TPN BAG 3 LITER Stedim, Inc. | KPE |
| Jul 16, 1991 | K910936 | EMPTY I.V. CONTAINER Ellis Pharmaceutical Consulting, Inc. | KPE |
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