FDA applicant
Fresenius Kabi AG
FDA records 14 decisions for Fresenius Kabi AG (Bad Homburg, DE) from 2013 to 2026: 14 510(k) clearances. Most are in product codes CAC (Apparatus, Autotransfusion) and FRN (Pump, Infusion). Since 2016 its 510(k)s took a median of 413 days from receipt to decision, against 270 for FDA’s reviews in the same codes and years. Its devices cite 15 predicates, 5 of them its own earlier devices. 4 recalls are linked to its devices, 1 Class I.
FDA’s records also spell it “Fresenius Kabi”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Fresenius Kabi AG’s devices, and how often a recall has named them.
FDA decisions per year
2in 2023
2026 so far, outlined.
Recalls per year
3in 2019
Class I Class II/III not classified
Planning a device like Fresenius Kabi AG’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Fresenius”
FDA records each applicant name separately; these may or may not be the same firm.