Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Fresenius Kabi AG — Predicate Candidate Screening

12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

270 daysmedian FDA review time
413 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K251139KabiHelp® Uno; KabiHelp® Advance plusFresenius Kabi AG2026-01-092700
K212445freeflex+ Transfer AdapterFresenius Kabi AG2022-06-013000
K210074Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Fresenius Kabi AG2022-03-014130
K210075Vigilant Software Suite – Vigilant Master MedFresenius Kabi AG2022-03-014130
K210073Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Fresenius Kabi AG2022-03-014130
K210089CATSmart, Automated Blood Processing Autotransfusion SystemFresenius Kabi AG2021-02-11290
K200530AMICUS Separator SystemFresenius Kabi AG2020-09-111930
K192150AMICUS Separator SystemFresenius Kabi AG2019-11-13960
K192368CATSmartFresenius Kabi AG2019-09-27280
K180831CATSmartFresenius Kabi AG2018-12-102550
K160735CATSmartFresenius Kabi AG2016-09-161830
K121613AGILIA INFUSION SYSTEMFresenius Kabi AG2013-05-013341

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda