FDA applicant
Becton, Dickinson & CO
FDA records 342 decisions for Becton, Dickinson & CO (Sparks, MD) from 2001 to 2026: 341 510(k) clearances and 1 original PMA approval. Most are in product codes LON (System, Test, Automated, Antimicrobial…) and JKA (Tubes, Vials, Systems, Serum Separators, Blood…). Since 2016 its 510(k)s took a median of 144 days from receipt to decision, against 175 for FDA’s reviews in the same codes and years. Its devices cite 619 predicates, 466 of them its own earlier devices. 156 recalls are linked to its devices, 1 Class I.
FDA’s records also spell it “Becton, Dickinson and Company”, “Becton, Dickinson and Co.”, “Becton Dickinson”, “Becton Dickinson & Company”, “Becton, Dickinson Company”, “Becton Dickinson and Company”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Becton, Dickinson & CO’s devices, and how often a recall has named them.
FDA decisions per year
11in 2025
2026 so far, outlined.
Recalls per year
3in 2026
Class I Class II/III not classified
Planning a device like Becton, Dickinson & CO’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 “Becton”
FDA records each applicant name separately; these may or may not be the same firm.