Medical Device Manufacturer · US , Round Lake , IL

Baxter Healthcare Corporation

61 submissions · 60 cleared · Since 2004
61
Total
60
Cleared
1
Denied

Baxter Healthcare Corporation — FDA 510(k) Submissions

Baxter Healthcare Corporation has submitted 61 FDA 510(k) premarket notifications since 2004, of which 60 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Set, Administration, Intravascular, Pump, Infusion, Dialyzer, High Permeability With Or Without Sealed Dialysate System, Filler, Bone Void, Calcium Compound, Set, Blood Transfusion . Use the specialty filter in the sidebar to narrow results.

61 devices
1–25 of 61
Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)
K251745 · DXQ Blood Pressure Cuff · Cardiovascular
Dec 2025 193d
Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
K251636 · FRN Pump, Infusion · General Hospital
Jul 2025 60d
SIGMA Spectrum Infusion Pump with Master Drug Library
K251640 · FRN Pump, Infusion · General Hospital
Jul 2025 60d
Solution Administration Sets
K243529 · FPA Set, Administration,... · General Hospital
Mar 2025 120d
Intravascular Extension Sets and Accessories
K242339 · FPA Set, Administration,... · General Hospital
Feb 2025 205d
Novum IQ Syringe Pump (40800BAXUS)
K242390 · FRN Pump, Infusion · General Hospital
Sep 2024 24d
Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS
K241564 · MQV Filler, Bone Void,... · Orthopedic
Aug 2024 63d
Novum IQ Large Volume Pump
K211122 · FRN Pump, Infusion · General Hospital
Mar 2024 1079d
Dose IQ Safety Software
K230665 · PHC Infusion Safety... · General Hospital
Mar 2024 385d
CleanCart A, CleanCart C, AK 98 Hemodialysis Machine
K232467 · KDI Dialyzer, High... · Gastroenterology & Urology
Sep 2023 30d
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library
K230022 · FRN Pump, Infusion · General Hospital
Mar 2023 86d
Spectrum IQ Infusion System with Dose IQ Safety Software
K230041 · FRN Pump, Infusion · General Hospital
Mar 2023 84d
lntravascular Administration Sets with Stopcock and Manifold
K223175 · FMG Stopcock, I.v. Set · General Hospital
Mar 2023 150d
Blood Administration Sets
K220558 · BRZ Set, Blood Transfusion · General Hospital
Nov 2022 262d
PCA Syringe Sets
K212262 · FPA Set, Administration,... · General Hospital
Oct 2022 440d
Spectrum IQ Infusion System with Dose IQ Safety Software
K222048 · FRN Pump, Infusion · General Hospital
Sep 2022 56d
Dose IQ Safety Software
K211124 · PHC Infusion Safety... · General Hospital
Aug 2022 502d
Novum IQ Syringe Pump
K211125 · FRN Pump, Infusion · General Hospital
Aug 2022 502d
Spectrum IQ Infusion System with Dose IQ Safety Software
K220417 · FRN Pump, Infusion · General Hospital
Apr 2022 74d
Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set
K212216 · KDI Dialyzer, High... · Gastroenterology & Urology
Apr 2022 259d
15L Cycler Drainage Bag
K214016 · KDJ Set, Administration, For... · Gastroenterology & Urology
Mar 2022 86d
Revaclear 500, Revaclear 400, Revaclear 300
K213639 · KDI Dialyzer, High... · Gastroenterology & Urology
Jan 2022 67d
PCEA Syringe Set
K211649 · PWH Administrations Sets With... · General Hospital
Nov 2021 179d
U9000 Plus Ultrafilter
K211035 · FIP Subsystem, Water... · Gastroenterology & Urology
Oct 2021 195d
Intravascular Administration Sets
K203609 · FPA Set, Administration,... · General Hospital
Sep 2021 294d
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