FDA applicant
Bd
FDA records 15 decisions for Bd (Franklin Lakes, NJ) from 2001 to 2026: 15 510(k) clearances. Most are in product codes PSZ (Devices Detecting Influenza A, B, And C Virus…) and FQH (Lavage, Jet). Since 2016 its 510(k)s took a median of 29 days from receipt to decision, against 29 for FDA’s reviews in the same codes and years. Its devices cite 33 predicates, 4 of them its own earlier devices. 11 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Bd’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
1in 2022
Class I Class II/III not classified
Planning a device like Bd’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