FDA applicant
B.Braun Medical, Inc.
FDA records 153 decisions for B.Braun Medical, Inc. (Allentown, PA) from 1993 to 2026: 153 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and FOZ (Catheter, Intravascular, Therapeutic…). Since 2016 its 510(k)s took a median of 197 days from receipt to decision, against 191 for FDA’s reviews in the same codes and years. Its devices cite 244 predicates, 74 of them its own earlier devices. 215 recalls are linked to its devices, 12 Class I.
FDA’s records also spell it “B. Braun Medical AG”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided B.Braun Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
85in 2025
Class I Class II/III not classified
Planning a device like B.Braun Medical, Inc.’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) Report