Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Baxter Healthcare Corporation · Predicate Candidate Screening
61 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
110 daysmedian FDA review time
355 days90th percentile
61clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251745 | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood | Baxter Healthcare Corporation | 2025-12-16 | 193 | 0 |
| K251636 | Spectrum IQ Infusion System with Dose IQ Safety Software (35 | Baxter Healthcare Corporation | 2025-07-28 | 60 | 1 |
| K251640 | SIGMA Spectrum Infusion Pump with Master Drug Library | Baxter Healthcare Corporation | 2025-07-28 | 60 | 1 |
| K243529 | Solution Administration Sets | Baxter Healthcare Corporation | 2025-03-14 | 120 | 1 |
| K242339 | Intravascular Extension Sets and Accessories | Baxter Healthcare Corporation | 2025-02-28 | 205 | 0 |
| K242390 | Novum IQ Syringe Pump (40800BAXUS) | Baxter Healthcare Corporation | 2024-09-05 | 24 | 3 |
| K241564 | Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPO | Baxter Healthcare Corporation | 2024-08-02 | 63 | 0 |
| K211122 | Novum IQ Large Volume Pump | Baxter Healthcare Corporation | 2024-03-29 | 1079 | 3 |
| K230665 | Dose IQ Safety Software | Baxter Healthcare Corporation | 2024-03-29 | 385 | 0 |
| K232467 | CleanCart A, CleanCart C, AK 98 Hemodialysis Machine | Baxter Healthcare Corporation | 2023-09-14 | 30 | 1 |
| K230022 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library | Baxter Healthcare Corporation | 2023-03-31 | 86 | 5 |
| K230041 | Spectrum IQ Infusion System with Dose IQ Safety Software | Baxter Healthcare Corporation | 2023-03-31 | 84 | 7 |
| K223175 | lntravascular Administration Sets with Stopcock and Manifold | Baxter Healthcare Corporation | 2023-03-10 | 150 | 0 |
| K220558 | Blood Administration Sets | Baxter Healthcare Corporation | 2022-11-17 | 262 | 0 |
| K212262 | PCA Syringe Sets | Baxter Healthcare Corporation | 2022-10-03 | 440 | 0 |
| K222048 | Spectrum IQ Infusion System with Dose IQ Safety Software | Baxter Healthcare Corporation | 2022-09-06 | 56 | 0 |
| K211124 | Dose IQ Safety Software | Baxter Healthcare Corporation | 2022-08-30 | 502 | 0 |
| K211125 | Novum IQ Syringe Pump | Baxter Healthcare Corporation | 2022-08-30 | 502 | 1 |
| K220417 | Spectrum IQ Infusion System with Dose IQ Safety Software | Baxter Healthcare Corporation | 2022-04-29 | 74 | 0 |
| K212216 | Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 | Baxter Healthcare Corporation | 2022-04-01 | 259 | 3 |
| K214016 | 15L Cycler Drainage Bag | Baxter Healthcare Corporation | 2022-03-18 | 86 | 0 |
| K213639 | Revaclear 500, Revaclear 400, Revaclear 300 | Baxter Healthcare Corporation | 2022-01-24 | 67 | 0 |
| K211649 | PCEA Syringe Set | Baxter Healthcare Corporation | 2021-11-23 | 179 | 0 |
| K211035 | U9000 Plus Ultrafilter | Baxter Healthcare Corporation | 2021-10-19 | 195 | 0 |
| K203609 | Intravascular Administration Sets | Baxter Healthcare Corporation | 2021-09-30 | 294 | 5 |
| K210430 | Intravascular Extension Set | Baxter Healthcare Corporation | 2021-06-18 | 126 | 0 |
| K210335 | Blood Administration Set | Baxter Healthcare Corporation | 2021-06-10 | 125 | 0 |
| K201867 | Homechoice Claria APD System, Sharesource Connectivity Platf | Baxter Healthcare Corporation | 2020-11-19 | 135 | 2 |
| DEN190042 | Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 D | Baxter Healthcare Corporation | 2020-08-28 | 347 | 0 |
| K192366 | Intravascular Extension Sets and Accessories | Baxter Healthcare Corporation | 2020-07-20 | 325 | 0 |
| K201464 | Altapore MIS | Baxter Healthcare Corporation | 2020-06-30 | 28 | 0 |
| K200640 | ALTAPORE SHAPE | Baxter Healthcare Corporation | 2020-05-08 | 58 | 0 |
| K193482 | PrisMax System Version 3 | Baxter Healthcare Corporation | 2020-03-13 | 87 | 2 |
| K192363 | Altapore | Baxter Healthcare Corporation | 2020-01-09 | 132 | 0 |
| K191513 | Altapore Shape | Baxter Healthcare Corporation | 2019-10-19 | 134 | 0 |
| K180739 | Clearlink System Solution Set | Baxter Healthcare Corporation | 2019-05-28 | 432 | 6 |
| K181225 | ALTAPORE | Baxter Healthcare Corporation | 2018-08-31 | 115 | 0 |
| K181306 | Actifuse Flow | Baxter Healthcare Corporation | 2018-08-17 | 92 | 0 |
| K173084 | Spectrum IQ Infusion System, Dose IQ Safety Software | Baxter Healthcare Corporation | 2018-05-11 | 224 | 4 |
| K171671 | Prismaflex System 8.10 | Baxter Healthcare Corporation | 2018-02-23 | 262 | 0 |
| K172544 | IV Fat Emulsion Administration Sets | Baxter Healthcare Corporation | 2017-09-22 | 30 | 0 |
| K161808 | Solution Set with 1.2 Micron Air Eliminating Filter | Baxter Healthcare Corporation | 2017-06-21 | 355 | 0 |
| K162887 | PrismaSATE | Baxter Healthcare Corporation | 2017-01-06 | 81 | 0 |
| K160007 | Paclitaxel Sets | Baxter Healthcare Corporation | 2016-12-19 | 350 | 0 |
| K161323 | Solution Set for Epidural Use | Baxter Healthcare Corporation | 2016-11-30 | 203 | 0 |
| K153158 | Solution Administration Sets with 0.2 Micron Filter | Baxter Healthcare Corporation | 2015-12-28 | 56 | 2 |
| K152129 | FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniC | Baxter Healthcare Corporation | 2015-10-29 | 90 | 1 |
| K150860 | Nitroglycerin Sets with DUO-VENT Spike | Baxter Healthcare Corporation | 2015-04-16 | 15 | 0 |
| K142600 | VIAL-MATE Adaptor | Baxter Healthcare Corporation | 2014-11-19 | 65 | 0 |
| K142011 | SOLUTION SET/EXTENSION SET | Baxter Healthcare Corporation | 2014-08-18 | 25 | 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