FDA applicant
Beckman Coulter, Inc.
FDA records 286 decisions for Beckman Coulter, Inc. (Brea, CA) from 1986 to 2026: 280 510(k) clearances, 1 De Novo grant and 5 original PMA approvals. Most are in product codes GKZ (Counter, Differential Cell) and LTT (Panels, Test, Susceptibility, Antimicrobial). Since 2016 its 510(k)s took a median of 161 days from receipt to decision, against 145 for FDA’s reviews in the same codes and years. Its devices cite 292 predicates, 150 of them its own earlier devices. 316 recalls are linked to its devices, 4 Class I.
FDA’s records also spell it “Beckman Coulter”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Beckman Coulter, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
11in 2025
2026 so far, outlined.
Recalls per year
7in 2026
Class I Class II/III not classified
Planning a device like Beckman Coulter, 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) ReportOther applicant names beginning “Beckman”
FDA records each applicant name separately; these may or may not be the same firm.