FDA applicant
Biosense Webster, Inc.
FDA records 84 decisions for Biosense Webster, Inc. (Diamond Bar, CA) from 1997 to 2026: 76 510(k) clearances and 8 original PMA approvals. Most are in product codes DQK (Computer, Diagnostic, Programmable) and DRF (Catheter, Electrode Recording, Or Probe…). Since 2016 its 510(k)s took a median of 123 days from receipt to decision, against 132 for FDA’s reviews in the same codes and years. Its devices cite 99 predicates, 72 of them its own earlier devices. 50 recalls are linked to its devices, 1 Class I.
FDA’s records also spell it “Biosense Webster”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Biosense Webster, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Biosense Webster, 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 “Biosense”
FDA records each applicant name separately; these may or may not be the same firm.