Chrysalis Intelligence · Sponsors · Fresenius Kabi AG

Fresenius Kabi AG

Bad Homburg, DE · 9 510(k) clearances

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Total clearances
9
2020-09-11 → 2026-01-09
Last 12 months
1
Product codes
7
Most recent
2026-01-09
Name variants in FDA filings: Fresenius Kabi / Fresenius Kabi AG
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
FPA — — — 2 2023-06-16
FRN Pump, Infusion Class II General Hospital 2 2022-03-01
KPE Container, I.V. Class II General Hospital 1 2026-01-09
LHI Set, I.V. Fluid Transfer Class II General Hospital 1 2022-06-01
PHC Infusion Safety Management Software Class II General Hospital 1 2022-03-01
CAC Apparatus, Autotransfusion Class II Anesthesiology 1 2021-02-11
GKT Separator, Automated, Blood Cell, Diagnostic Class II Hematology 1 2020-09-11
Filings

All 510(k) clearances (9)

Date K-number Device Code Class Specialty
2026-01-09 K251139 KabiHelp® Uno; KabiHelp® Advance plus KPE Class II General Hospital
2023-06-16 K221121 Volumat Polyethylene I.V. Administration Set FPA — —
2023-06-02 K220301 Volumat Line FPA — —
2022-06-01 K212445 freeflex+ Transfer Adapter LHI Class II General Hospital
2022-03-01 K210075 Vigilant Software Suite – Vigilant Master Med PHC Class II General Hospital
2022-03-01 K210074 Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable FRN Class II General Hospital
2022-03-01 K210073 Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo FRN Class II General Hospital
2021-02-11 K210089 CATSmart, Automated Blood Processing Autotransfusion System CAC Class II Anesthesiology
2020-09-11 K200530 AMICUS Separator System GKT Class II Hematology
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence