FDA applicant
Inquis Medical
FDA records 10 decisions for Inquis Medical (Menlo Park, CA) from 2023 to 2026: 10 510(k) clearances. Most are in product codes QEW (Peripheral Mechanical Thrombectomy With…) and QEZ (Aspiration Thrombectomy Catheter). Since 2016 its 510(k)s took a median of 56 days from receipt to decision, against 78 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 6 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Inquis Medical’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like Inquis Medical’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