Medical Device Manufacturer · US , Lake Zurich , IL

Fresenius Kabi AG

12 submissions · 12 cleared · Since 2013
12
Total
12
Cleared
0
Denied

Fresenius Kabi AG — FDA 510(k) Submissions

Fresenius Kabi AG has submitted 12 FDA 510(k) premarket notifications since 2013, of which 12 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Apparatus, Autotransfusion, Pump, Infusion, Separator, Automated, Blood Cell And Plasma, Therapeutic, Separator, Automated, Blood Cell, Diagnostic, Infusion Safety Management Software . Use the specialty filter in the sidebar to narrow results.

12 devices
1–12 of 12
KabiHelp? Uno; KabiHelp? Advance plus
K251139 · KPE Container, I.v. · General Hospital
Jan 2026 270d
freeflex+ Transfer Adapter
K212445 · LHI Set, I.v. Fluid Transfer · General Hospital
Jun 2022 300d
Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo
K210073 · FRN Pump, Infusion · General Hospital
Mar 2022 413d
Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable
K210074 · FRN Pump, Infusion · General Hospital
Mar 2022 413d
Vigilant Software Suite ? Vigilant Master Med
K210075 · PHC Infusion Safety... · General Hospital
Mar 2022 413d
CATSmart, Automated Blood Processing Autotransfusion System
K210089 · CAC Apparatus, Autotransfusion · Cardiovascular
Feb 2021 29d
AMICUS Separator System
K200530 · GKT Separator, Automated,... · Gastroenterology & Urology
Sep 2020 193d
AMICUS Separator System
K192150 · LKN Separator, Automated,... · Gastroenterology & Urology
Nov 2019 96d
CATSmart
K192368 · CAC Apparatus, Autotransfusion · Cardiovascular
Sep 2019 28d
CATSmart
K180831 · CAC Apparatus, Autotransfusion · Cardiovascular
Dec 2018 255d
CATSmart
K160735 · CAC Apparatus, Autotransfusion · Anesthesiology
Sep 2016 183d
AGILIA INFUSION SYSTEM
K121613 · FRN Pump, Infusion · General Hospital
May 2013 334d
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