FDA applicant
AtriCure, Inc.
FDA records 62 decisions for AtriCure, Inc. (Mason, OH) from 2001 to 2026: 60 510(k) clearances and 2 original PMA approvals. Most are in product codes OCL (Surgical Device, For Cutting, Coagulation…) and FZP (Clip, Implantable). Since 2016 its 510(k)s took a median of 30 days from receipt to decision, against 66 for FDA’s reviews in the same codes and years. Its devices cite 122 predicates, 78 of them its own earlier devices. 6 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided AtriCure, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
2in 2023
Class I Class II/III not classified
Planning a device like AtriCure, 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) Report