FDA applicant
Acclarent, Inc.
FDA records 45 decisions for Acclarent, Inc. (Rmenlo Park, CA) from 2005 to 2026: 44 510(k) clearances and 1 De Novo grant. Most are in product codes LRC (Instrument, Ent Manual Surgical) and KAM (Cannula, Sinus). Since 2016 its 510(k)s took a median of 122 days from receipt to decision, against 100 for FDA’s reviews in the same codes and years. Its devices cite 72 predicates, 35 of them its own earlier devices. 15 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Acclarent, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2023
2026 so far, outlined.
Recalls per year
2in 2025
Class I Class II/III not classified
Planning a device like Acclarent, 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