Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

63 results for "Baxter Healthcare Corporation"
1–24 of 63
Search insights Median review: 110d Cleared: 98% Top manufacturer: Baxter Healthcare Corporation Lead specialty: General Hospital
Cleared Dec 16, 2025
Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)
K251745 · DXQ
Baxter Healthcare Corporation
Cardiovascular · 193d
Cleared Jul 28, 2025
SIGMA Spectrum Infusion Pump with Master Drug Library
K251640 · FRN
Baxter Healthcare Corporation
General Hospital · 60d
Cleared Jul 28, 2025
Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
K251636 · FRN
Baxter Healthcare Corporation
General Hospital · 60d
Cleared Mar 14, 2025
Solution Administration Sets
K243529 · FPA
Baxter Healthcare Corporation
General Hospital · 120d
Cleared Feb 28, 2025
Intravascular Extension Sets and Accessories
K242339 · FPA
Baxter Healthcare Corporation
General Hospital · 205d
Cleared Sep 05, 2024
Novum IQ Syringe Pump (40800BAXUS)
K242390 · FRN
Baxter Healthcare Corporation
General Hospital · 24d
Cleared Aug 02, 2024
Actifuse ABX
K241564 · MQV
Baxter Healthcare Corporation
Orthopedic · 63d
Cleared Mar 29, 2024
Dose IQ Safety Software
K230665 · PHC
Baxter Healthcare Corporation
General Hospital · 385d
Cleared Mar 29, 2024
Novum IQ Large Volume Pump
K211122 · FRN
Baxter Healthcare Corporation
General Hospital · 1079d
Cleared Sep 14, 2023
CleanCart A, CleanCart C, AK 98 Hemodialysis Machine
K232467 · KDI
Baxter Healthcare Corporation
Gastroenterology & Urology · 30d
Cleared Mar 31, 2023
Spectrum IQ Infusion System with Dose IQ Safety Software
K230041 · FRN
Baxter Healthcare Corporation
General Hospital · 84d
Cleared Mar 31, 2023
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library
K230022 · FRN
Baxter Healthcare Corporation
General Hospital · 86d
Cleared Mar 10, 2023
lntravascular Administration Sets with Stopcock and Manifold
K223175 · FMG
Baxter Healthcare Corporation
General Hospital · 150d
Cleared Nov 17, 2022
Blood Administration Sets
K220558 · BRZ
Baxter Healthcare Corporation
General Hospital · 262d
Cleared Oct 03, 2022
PCA Syringe Sets
K212262 · FPA
Baxter Healthcare Corporation
General Hospital · 440d
Cleared Sep 06, 2022
Spectrum IQ Infusion System with Dose IQ Safety Software
K222048 · FRN
Baxter Healthcare Corporation
General Hospital · 56d
Cleared Aug 30, 2022
Novum IQ Syringe Pump
K211125 · FRN
Baxter Healthcare Corporation
General Hospital · 502d
Cleared Aug 30, 2022
Dose IQ Safety Software
K211124 · PHC
Baxter Healthcare Corporation
General Hospital · 502d
Cleared Apr 29, 2022
Spectrum IQ Infusion System with Dose IQ Safety Software
K220417 · FRN
Baxter Healthcare Corporation
General Hospital · 74d
Cleared Apr 01, 2022
Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set
K212216 · KDI
Baxter Healthcare Corporation
Gastroenterology & Urology · 259d
Cleared Mar 18, 2022
15L Cycler Drainage Bag
K214016 · KDJ
Baxter Healthcare Corporation
Gastroenterology & Urology · 86d
Cleared Jan 24, 2022
Revaclear 500, Revaclear 400, Revaclear 300
K213639 · KDI
Baxter Healthcare Corporation
Gastroenterology & Urology · 67d
Cleared Nov 23, 2021
PCEA Syringe Set
K211649 · PWH
Baxter Healthcare Corporation
General Hospital · 179d
Cleared Oct 19, 2021
U9000 Plus Ultrafilter
K211035 · FIP
Baxter Healthcare Corporation
Gastroenterology & Urology · 195d