FDA applicant
Penumbra, Inc.
FDA records 88 decisions for Penumbra, Inc. (Alameda, CA) from 2005 to 2026: 88 510(k) clearances. Most are in product codes QEW (Peripheral Mechanical Thrombectomy With…) and NRY (Catheter, Thrombus Retriever). Since 2016 its 510(k)s took a median of 96 days from receipt to decision, against 89 for FDA’s reviews in the same codes and years. Its devices cite 135 predicates, 120 of them its own earlier devices. 12 recalls are linked to its devices, 5 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Penumbra, 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 2026
Class I Class II/III not classified
Planning a device like Penumbra, Inc.’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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