Fresenius Kabi AG
Fresenius Kabi AG appears in FDA public data with 0 recalls, 14 510(k) clearances, 9 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on January 9, 2026.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 14
- Inspections
- 9
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K251139 | KabiHelp® Uno; KabiHelp® Advance plus | January 9, 2026 |
| K221121 | Volumat Polyethylene I.V. Administration Set | June 16, 2023 |
| K220301 | Volumat Line | June 2, 2023 |
| K212445 | freeflex+ Transfer Adapter | June 1, 2022 |
| K210075 | Vigilant Software Suite Vigilant Master Med | March 1, 2022 |
| K210074 | Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cabl | March 1, 2022 |
| K210073 | Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agili | March 1, 2022 |
| K210089 | CATSmart, Automated Blood Processing Autotransfusion System | February 11, 2021 |
| K200530 | AMICUS Separator System | September 11, 2020 |
| K192150 | AMICUS Separator System | November 13, 2019 |
| K192368 | CATSmart | September 27, 2019 |
| K180831 | CATSmart | December 10, 2018 |
| K160735 | CATSmart | September 16, 2016 |
| K121613 | AGILIA INFUSION SYSTEM | May 1, 2013 |