# Fresenius Kabi AG

- Location (FDA's records): Bad Homburg, DE
- FDA decisions: 14 (2013–2026): 14 510(k) clearances
- Names in FDA's records: Fresenius Kabi AG (12); Fresenius Kabi (2)
- Product codes: CAC (4), FRN (3), FPA (2), PHC (1), KPE (1), LKN (1), GKT (1), LHI (1)
- 510(k) review time since 2016: median 413 days, against 270 for FDA's reviews in the same codes and years (1 of 7 faster)
- Predicates its devices cite: 15 (5 its own); citations of its devices by later devices: 5 (5 its own)
- Recalls linked to its devices: 4 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Fresenius AG: 2 (https://510kreport.com/company/fresenius)
- Baxter Healthcare Corp: 2 (https://510kreport.com/company/baxter-healthcare)
- B.Braun Medical, Inc.: 2 (https://510kreport.com/company/b-braun-medical)
- Haemotronic, Inc.: 1 (https://510kreport.com/company/haemotronic)
- Fresenius Kabi USA,Llc: 1 (https://510kreport.com/company/fresenius-kabi-usa)
- Carefusion 303, Inc.: 1 (https://510kreport.com/company/carefusion-303)
- West Pharmaceutical Services Az, Inc.: 1 (https://510kreport.com/company/west-pharmaceutical-services-az)

## Its most-cited devices
- K121613: Agilia Infusion System (2013), cited by 2
- K192368: CATSmart (2019), cited by 1
- K192150: AMICUS Separator System (2019), cited by 1
- K180831: CATSmart (2018), cited by 1

## Recent decisions
- K251139: KabiHelp® Uno; KabiHelp® Advance plus (Jan 9, 2026)
- K221121: Volumat Polyethylene I.V. Administration Set (Jun 16, 2023)
- K220301: Volumat Line (Jun 2, 2023)
- K212445: freeflex+ Transfer Adapter (Jun 1, 2022)
- K210075: Vigilant Software Suite – Vigilant Master Med (Mar 1, 2022)
- K210073: Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo (Mar 1, 2022)
- K210074: Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable (Mar 1, 2022)
- K210089: CATSmart, Automated Blood Processing Autotransfusion System (Feb 11, 2021)

Source page: https://510kreport.com/company/fresenius-kabi