FDA Product Code
FDA Product Code KPE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5025
510(k) Clearances — 117 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252079 | Disposable Infusion Bag for Parenteral Nutrition | Beijing L&Z Medical Technology Development Co., Ltd. | 2026-04-02 | Traditional | PDF ↗ |
| K251980 | ClaveQS Bag | Icu Medical, Inc. | 2026-03-20 | Traditional | PDF ↗ |
| K251139 | KabiHelp® Uno; KabiHelp® Advance plus | Fresenius Kabi AG | 2026-01-09 | Traditional | PDF ↗ |
| K252094 | eZSURE Empty Fluid Container | Epic Medical Pte. , Ltd. | 2025-08-01 | Special | PDF ↗ |
| K250459 | DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution | Technoflex Sas. | 2025-04-18 | Traditional | PDF ↗ |
| K241442 | eZSURE Empty Fluid Container with ProSeal Injection Site | Epic Medical Pte. , Ltd. | 2024-06-21 | Special | PDF ↗ |
| K223674 | eZSURE Empty Fluid Container (models 426030, 426040, 426110) | Epic Medical Pte. , Ltd. | 2023-09-01 | Traditional | PDF ↗ |
| K222622 | Disposable Infusion Bag for Parenteral Nutrition | Beijing L&Z Medical Technology Development Co., Ltd. | 2023-02-16 | Traditional | PDF ↗ |
| K210749 | Empty EVA Bag | Haemotronic S.P.A. | 2021-08-19 | Traditional | PDF ↗ |
| K201936 | SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL | Gilero, LLC | 2021-05-06 | Traditional | PDF ↗ |
| K193528 | Empty EVA Bag | Haemotronic S.P.A. | 2020-07-22 | Traditional | PDF ↗ |
| K190328 | HCT Empty EVA Container Pack | Health Care Technologies | 2019-08-15 | Traditional | PDF ↗ |
| K190305 | Additive Cap | International Medical Industries, Inc. | 2019-04-30 | Traditional | PDF ↗ |
| K181393 | Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP | Valmed S.R.L. | 2019-02-15 | Traditional | PDF ↗ |
| K132276 | STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML | Hospira, Inc. | 2013-11-12 | Traditional | PDF ↗ |
| K121161 | EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER | Acta Medical, LLC | 2012-07-13 | Traditional | PDF ↗ |
| K111217 | ADDITIVE CAP | Baxter Healthcare Corp | 2011-06-14 | Traditional | PDF ↗ |
| K101412 | EVA TPN BAG | Valmed S.R.L. | 2011-04-13 | Traditional | PDF ↗ |
| K090096 | ALL-IN-ONE CONTAINER | Baxter Healthcare Corporation | 2009-01-30 | Traditional | PDF ↗ |
| K073538 | DUAL CHAMBER TPN CONTAINER | B.Braun Medical, Inc. | 2008-03-12 | Traditional | PDF ↗ |
| K061197 | KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER | Kawasumi Laboratories, Inc. | 2006-06-30 | Traditional | PDF ↗ |
| K041038 | CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER | Churchill Medical Systems, Inc. | 2004-12-21 | Abbreviated | PDF ↗ |
| K041415 | EVA TPN CONTAINER | B.Braun Medical, Inc. | 2004-08-04 | Traditional | PDF ↗ |
| K033916 | GRI-BAG, GRI-BAG AP | Laboratorios Grifols, S.A. | 2003-12-30 | Traditional | PDF ↗ |
| K031419 | GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML | Laboratorios Grifols, S.A. | 2003-11-24 | Traditional | PDF ↗ |
| K030888 | EVA EMPTY SOLUTION CONTAINER | Metrix Co. | 2003-04-02 | Special | PDF ↗ |
| K020485 | ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML | Baxter Healthcare Corp | 2002-03-12 | Special | PDF ↗ |
| K001461 | TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET | Biometrix , Ltd. | 2000-09-11 | Traditional | PDF ↗ |
| K001287 | EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML | Sorenson Medical, Inc. | 2000-06-09 | Traditional | PDF ↗ |
| K983294 | ALL-IN-ONE CONTAINER CAT#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112, 2B8117M 2B8122, 2B8132, 2B8142, 2B712 | Baxter Healthcare Corp | 1998-11-03 | Traditional | PDF ↗ |
| K982048 | MPS RESERVOIR BAG | Medical Product Specialists | 1998-07-27 | Traditional | PDF ↗ |
| K974180 | STERI-TAMP | Pharmacy, Inc. | 1998-02-24 | Traditional | PDF ↗ |
| K973103 | CHARTERMED TPN-EVA BAGS | Chartermed, Inc. | 1997-11-24 | Traditional | PDF ↗ |
| K972464 | VITALMIX PLUS EMPTY I.V. CONTAINER | Pacific Device, Inc. | 1997-11-05 | Traditional | PDF ↗ |
| K964853 | INTRAVIA CONTAINER, EMPTY | Baxter Healthcare Corp | 1997-03-31 | Traditional | PDF ↗ |
| K960581 | SECURE EVA DUAL CHAMBER MIXING BAG | Secure Medical Products, Inc. | 1996-04-30 | Traditional | PDF ↗ |
| K945193 | ALL-IN-ONE TWO CHAMBER CONTAINER | Baxter Healthcare Corp | 1995-05-12 | Traditional | PDF ↗ |
| K941731 | EMPTY, SOLUTION TRANSFER CONTAINER WITH DETATCHABLE LEG SET | Incutech, Inc. | 1994-07-22 | Traditional | PDF ↗ |
| K932477 | UNIMIX CONAINER-EMPTY CONTAINER W/3 LEAD TRANS.SET | Baxter Healthcare Corp | 1994-06-10 | Traditional | PDF ↗ |
| K934179 | DISPOSABLE BAG DECANTER | Byron Medical | 1994-05-23 | Traditional | PDF ↗ |
| K940258 | SOLUTION TRANSFER CONTAINER W/ATTACHED LEG SET (EMPTY) | Incutech, Inc. | 1994-03-28 | Traditional | PDF ↗ |
| K932649 | PHARMAFEED | Plasco, Inc. | 1993-11-16 | Traditional | PDF ↗ |
| K932641 | EMPTY MIXING CONTAINER | Douglas Medical Products Corp. | 1993-11-10 | Traditional | PDF ↗ |
| K932640 | EVA EMPTY MIXING CONTAINER | Douglas Medical Products Corp. | 1993-11-10 | Traditional | PDF ↗ |
| K926123 | DUAL CHAMBER MIXING BAG | Secure Medical, Inc. | 1993-09-03 | Traditional | PDF ↗ |
| K923448 | EMPTY SOLUTION TRANSFER CONTAINER W/ DETACH LEG | Healthtek, Inc. | 1993-07-28 | Traditional | PDF ↗ |
| K922214 | EMPTY VIAFLEX PLASTIC CONTAINER | Baxter Healthcare Corp | 1993-03-26 | Traditional | PDF ↗ |
| K913608 | SNAPPER | Healthtek, Inc. | 1991-11-29 | Traditional | PDF ↗ |
| K911567 | DUAL COMPARTMENT TPN BAG 3 LITER | Stedim, Inc. | 1991-08-02 | Traditional | PDF ↗ |
| K910936 | EMPTY I.V. CONTAINER | Ellis Pharmaceutical Consulting, Inc. | 1991-07-16 | Traditional | PDF ↗ |
| K911576 | CHEMOTHERAPY CONTAINER | Bemis Mfg. Co. | 1991-07-05 | Traditional | PDF ↗ |
| K910673 | BAG SPIGOT | Procedure Products, Inc. | 1991-04-24 | Traditional | PDF ↗ |
| K902079 | ADMIXTURE CONTAINER FOR TOTAL PARENTERAL NUTRITION | Chartermed, Inc. | 1990-10-29 | Traditional | PDF ↗ |
| K902464 | CHARTERMED EMPTY TPN CONTAINER - 100 ML CAPACITY | Chartermed, Inc. | 1990-08-30 | Traditional | PDF ↗ |
| K895924 | METRICARE DRUG RESERVOIRS | Metrix Co. | 1990-07-26 | Traditional | PDF ↗ |
| K883400 | OPTUM(TM) AUTOMATED PATIENT ASSIST DEVICE | Abbott Laboratories | 1989-12-01 | Traditional | PDF ↗ |
| K885173 | MIX CONTAINER W/ATTACHED TRANSFER SET | Medical Support Systems | 1989-06-07 | Traditional | PDF ↗ |
| K890095 | PVC EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET | Kells Medical, Inc. | 1989-05-24 | Traditional | PDF ↗ |
| K890094 | EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET | Kells Medical, Inc. | 1989-05-24 | Traditional | PDF ↗ |
| K891077 | MEDIVERSE PARENTERAL NUTRITION BAG | Mediflex Intl. | 1989-05-24 | Traditional | PDF ↗ |
| K890268 | PRESSURE INFUSOR FOR I.V. BAGS/AUTOINFLATION | Biomedical Dynamics, Inc. | 1989-05-05 | Traditional | PDF ↗ |
| K890272 | BAG DECANTER | Superior Medical Products | 1989-03-14 | Traditional | PDF ↗ |
| K880506 | MODIFIED EVA-MIX AND DI-MIX BAGS | Gil-Med Industries C/O Kegan & Kegan, Ltd. | 1988-05-20 | Traditional | PDF ↗ |
| K875155 | 60 ML RESERVOIR BAG, ITEM #200 | Prn Services, Inc. | 1988-02-16 | Traditional | PDF ↗ |
| K870395 | CHURCHILL PARENTERAL NUTRITION BAG - EVA | Churchill Corp. | 1987-10-15 | Traditional | PDF ↗ |
| K871449 | ONCOLOGY SPT SYS #MS-C10 MEDICATION RESERVOIR BAG | Pa Medical Corp. | 1987-06-17 | Traditional | PDF ↗ |
| K870052 | INFUMIX MIXING CONTAINER | Biodynamics Corp. | 1987-02-27 | Traditional | PDF ↗ |
| K870113 | THERMAL JACKET FOR I.V. FLUID BAGS | Thermal Medical Systems, Inc. | 1987-02-25 | Traditional | PDF ↗ |
| K870274 | DI-MIX PARENTERAL NUTRITION & MEDICINE CONTAINER | Gil-Med Industries C/O Kegan & Kegan, Ltd. | 1987-02-10 | Traditional | PDF ↗ |
| K863040 | DISPOSABLE INTRAVENOUS HYPERALIMENTATION BAGS | Cher Mel Corp. | 1986-10-31 | Traditional | PDF ↗ |
| K860042 | NUTRIMIX EMPTY CONTAINER | Abbott Laboratories | 1986-04-09 | Traditional | PDF ↗ |
| K854033 | SNAP-LOCK ADDITIVE CAP #SL400 | Williams Medical Co. | 1985-11-06 | Traditional | PDF ↗ |
| K854034 | SNAP-LOCK ADDITIVE CAP #SL 300 | Williams Medical Co. | 1985-11-06 | Traditional | PDF ↗ |
| K854031 | SNAP-LOCK ADDITIVE CAP #SL100 | Williams Medical Co. | 1985-11-06 | Traditional | PDF ↗ |
| K854032 | SNAP-LOCK ADDITIVE CAP #SL 200 | Williams Medical Co. | 1985-11-01 | Traditional | PDF ↗ |
| K852938 | TUF TRACK MODEL TT83 CUBICLE TRACK & IV83 INTR TRK | Northern Customfab, Inc. | 1985-09-30 | Traditional | PDF ↗ |
| K852893 | VIAL DECANTER | Advance Medical Designs, Inc. | 1985-09-20 | Traditional | PDF ↗ |
| K852777 | BAG DECANTER | Advance Medical Designs, Inc. | 1985-08-16 | Traditional | PDF ↗ |
| K852778 | BOTTLE DECANTER | Advance Medical Designs, Inc. | 1985-08-16 | Traditional | PDF ↗ |
| K850035 | EMPTY SOLUTION TRANSFER CONTAINER | The Healthcare Group Laboratories, Inc. | 1985-06-07 | Traditional | PDF ↗ |
| K844664 | THE I.V. BAG | Kabivitrum, Inc. | 1985-05-06 | Traditional | PDF ↗ |
| K844077 | NUTRIMIX EMPTY CONTAINER | Abbott Laboratories | 1985-02-15 | Traditional | PDF ↗ |
| K844410 | NUTRIBAG MIXING CONTAINER -2000 ML | Medical & Pharmaceutical Supplies, Inc. | 1984-11-28 | Traditional | PDF ↗ |
| K843954 | MIXING CONTAINER | American Mcgaw | 1984-11-28 | Traditional | PDF ↗ |
| K841597 | GIL-MED PARENTERAL NUTRITION OR MEDICINE | Gil-Med Industries C/O Kegan & Kegan, Ltd. | 1984-10-26 | Traditional | PDF ↗ |
| K842170 | EMPTY SOLUTION TRANSFER CONTAINER | The Healthcare Group Laboratories, Inc. | 1984-10-19 | Traditional | PDF ↗ |
| K843523 | EMPTY SOLUTION TRANSFER CONTAINER 1000 | Polymer Technology Corp. | 1984-10-16 | Traditional | PDF ↗ |
| K842629 | HOME NUTRIBAG MIXING CONTAINER 3000ML | Medical & Pharmaceutical Supplies, Inc. | 1984-09-07 | Traditional | PDF ↗ |
| K842628 | HOME NUTRIBAG MIXING CONTAINER 1000ML | Medical & Pharmaceutical Supplies, Inc. | 1984-09-07 | Traditional | PDF ↗ |
| K840915 | DIMIX CONTAINER FOR PARNETERAL NUTRIT | Gil-Med Industries C/O Kegan & Kegan, Ltd. | 1984-04-17 | Traditional | PDF ↗ |
| K840388 | PAB IV CONTAINER | American Mcgaw | 1984-03-06 | Traditional | PDF ↗ |
| K832247 | I.V. BAG ADDISEAL | Baxa Corp., Sub. of Cook Group, Inc. | 1983-07-26 | Traditional | PDF ↗ |
| K832254 | BAXA ADDISEAL | Baxa Corp., Sub. of Cook Group, Inc. | 1983-07-26 | Traditional | PDF ↗ |
| K830193 | CAT 3040 | Burron Medical Products, Inc. | 1983-03-09 | Traditional | PDF ↗ |
| K830450 | DELMED IV CONTAINER | Delmed, Inc. | 1983-03-01 | Traditional | PDF ↗ |
| K830299 | SOLUTION TRANSFER CONTAINER | The Healthcare Group Laboratories, Inc. | 1983-02-19 | Traditional | PDF ↗ |
| K830232 | DECANTER MODELS-VARIOUS | Steri-Sytems, Corp. | 1983-02-09 | Traditional | PDF ↗ |
| K823538 | POUR BOTTLE DECANTER #2010 | Medi-Plant Intl. | 1983-01-26 | Traditional | PDF ↗ |
| K820200 | IV ALERT SYSTEM | Allied Medical Technologies, Inc. | 1982-03-18 | Traditional | PDF ↗ |
| K820435 | BAXA ADDISEAL | Baxa Corp., Sub. of Cook Group, Inc. | 1982-03-08 | Traditional | PDF ↗ |
Product code KPE · Class II · General Hospital. Data: openFDA.