Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KPE — Predicate Candidate Screening
117 FDA 510(k) clearances under this product code; the 50 most recent screened below.
73 daysmedian FDA review time
268 days90th percentile
117clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252079 | Disposable Infusion Bag for Parenteral Nutrition | Beijing L&Z Medical Technology Development Co., Ltd. | 2026-04-02 | 274 | 0 |
| K251980 | ClaveQS™ Bag | Icu Medical, Inc. | 2026-03-20 | 266 | 0 |
| K251139 | KabiHelp® Uno; KabiHelp® Advance plus | Fresenius Kabi AG | 2026-01-09 | 270 | 0 |
| K252094 | eZSURE™ Empty Fluid Container | Epic Medical Pte. , Ltd. | 2025-08-01 | 29 | 0 |
| K250459 | DMRX 100ml Empty Container Solution; DMRX 250ml Empty Contai | Technoflex Sas. | 2025-04-18 | 59 | 0 |
| K241442 | eZSURE™ Empty Fluid Container with ProSeal™ Injection Site | Epic Medical Pte. , Ltd. | 2024-06-21 | 30 | 0 |
| K223674 | eZSURE™ Empty Fluid Container (models 426030, 426040, 426110 | Epic Medical Pte. , Ltd. | 2023-09-01 | 268 | 0 |
| K222622 | Disposable Infusion Bag for Parenteral Nutrition | Beijing L&Z Medical Technology Development Co., Ltd. | 2023-02-16 | 169 | 0 |
| K210749 | Empty EVA Bag | Haemotronic S.P.A. | 2021-08-19 | 160 | 0 |
| K201936 | SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 | Gilero, LLC | 2021-05-06 | 297 | 0 |
| K193528 | Empty EVA Bag | Haemotronic S.P.A. | 2020-07-22 | 216 | 0 |
| K190328 | HCT Empty EVA Container Pack | Health Care Technologies | 2019-08-15 | 183 | 2 |
| K190305 | Additive Cap | International Medical Industries, Inc. | 2019-04-30 | 77 | 0 |
| K181393 | Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM01 | Valmed S.R.L. | 2019-02-15 | 262 | 0 |
| K132276 | STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CO | Hospira, Inc. | 2013-11-12 | 113 | 0 |
| K121161 | EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION | Acta Medical, LLC | 2012-07-13 | 87 | 0 |
| K111217 | ADDITIVE CAP | Baxter Healthcare Corp | 2011-06-14 | 43 | 0 |
| K101412 | EVA TPN BAG | Valmed S.R.L. | 2011-04-13 | 328 | 0 |
| K090096 | ALL-IN-ONE CONTAINER | Baxter Healthcare Corporation | 2009-01-30 | 15 | 0 |
| K073538 | DUAL CHAMBER TPN CONTAINER | B.Braun Medical, Inc. | 2008-03-12 | 86 | 0 |
| K061197 | KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER | Kawasumi Laboratories, Inc. | 2006-06-30 | 63 | 0 |
| K041038 | CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER | Churchill Medical Systems, Inc. | 2004-12-21 | 243 | 0 |
| K041415 | EVA TPN CONTAINER | B.Braun Medical, Inc. | 2004-08-04 | 69 | 1 |
| K033916 | GRI-BAG, GRI-BAG AP | Laboratorios Grifols, S.A. | 2003-12-30 | 12 | 1 |
| K031419 | GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML | Laboratorios Grifols, S.A. | 2003-11-24 | 203 | 0 |
| K030888 | EVA EMPTY SOLUTION CONTAINER | Metrix Co. | 2003-04-02 | 12 | 16 |
| K020485 | ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML | Baxter Healthcare Corp | 2002-03-12 | 27 | 0 |
| K001461 | TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET | Biometrix , Ltd. | 2000-09-11 | 124 | 0 |
| K001287 | EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1 | Sorenson Medical, Inc. | 2000-06-09 | 46 | 0 |
| K983294 | ALL-IN-ONE CONTAINER CAT#'S 2B8114,2B8124, 2B8134, 2B8144, 2 | Baxter Healthcare Corp | 1998-11-03 | 43 | 0 |
| K982048 | MPS RESERVOIR BAG | Medical Product Specialists | 1998-07-27 | 47 | 0 |
| K974180 | STERI-TAMP | Pharmacy, Inc. | 1998-02-24 | 110 | 0 |
| K973103 | CHARTERMED TPN-EVA BAGS | Chartermed, Inc. | 1997-11-24 | 97 | 0 |
| K972464 | VITALMIX PLUS EMPTY I.V. CONTAINER | Pacific Device, Inc. | 1997-11-05 | 127 | 0 |
| K964853 | INTRAVIA CONTAINER, EMPTY | Baxter Healthcare Corp | 1997-03-31 | 118 | 3 |
| K960581 | SECURE EVA DUAL CHAMBER MIXING BAG | Secure Medical Products, Inc. | 1996-04-30 | 78 | 0 |
| K945193 | ALL-IN-ONE TWO CHAMBER CONTAINER | Baxter Healthcare Corp | 1995-05-12 | 200 | 0 |
| K941731 | EMPTY, SOLUTION TRANSFER CONTAINER WITH DETATCHABLE LEG SET | Incutech, Inc. | 1994-07-22 | 106 | 0 |
| K932477 | UNIMIX CONAINER-EMPTY CONTAINER W/3 LEAD TRANS.SET | Baxter Healthcare Corp | 1994-06-10 | 382 | 0 |
| K934179 | DISPOSABLE BAG DECANTER | Byron Medical | 1994-05-23 | 270 | 0 |
| K940258 | SOLUTION TRANSFER CONTAINER W/ATTACHED LEG SET (EMPTY) | Incutech, Inc. | 1994-03-28 | 66 | 0 |
| K932649 | PHARMAFEED | Plasco, Inc. | 1993-11-16 | 167 | 0 |
| K932640 | EVA EMPTY MIXING CONTAINER | Douglas Medical Products Corp. | 1993-11-10 | 161 | 0 |
| K932641 | EMPTY MIXING CONTAINER | Douglas Medical Products Corp. | 1993-11-10 | 161 | 0 |
| K926123 | DUAL CHAMBER MIXING BAG | Secure Medical, Inc. | 1993-09-03 | 273 | 0 |
| K923448 | EMPTY SOLUTION TRANSFER CONTAINER W/ DETACH LEG | Healthtek, Inc. | 1993-07-28 | 379 | 0 |
| K922214 | EMPTY VIAFLEX PLASTIC CONTAINER | Baxter Healthcare Corp | 1993-03-26 | 318 | 0 |
| K913608 | SNAPPER | Healthtek, Inc. | 1991-11-29 | 107 | 0 |
| K911567 | DUAL COMPARTMENT TPN BAG 3 LITER | Stedim, Inc. | 1991-08-02 | 115 | 0 |
| K910936 | EMPTY I.V. CONTAINER | Ellis Pharmaceutical Consulting, Inc. | 1991-07-16 | 132 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda