FDA applicant
Bd Diagnostic Systems
FDA records 7 decisions for Bd Diagnostic Systems (Sparks, MD) from 1999 to 2026: 6 510(k) clearances and 1 original PMA approval. Most are in product codes LON (System, Test, Automated, Antimicrobial…) and JWY (Manual Antimicrobial Susceptibility Test Systems). Its devices cite 10 predicates, 0 of them its own earlier devices. 11 recalls are linked to its devices.
FDA’s records also spell it “BD Diagnostic Systems”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Bd Diagnostic Systems’s devices, and how often a recall has named them.
FDA decisions per year
1in 2026
2026 so far, outlined.
Recalls per year
1in 2016
Class I Class II/III not classified
Planning a device like Bd Diagnostic Systems’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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