Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Inquis Medical · Predicate Candidate Screening

10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

57 daysmedian FDA review time
115 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K261105Powered Aventus Thrombectomy Systemâ„¢Inquis Medical2026-07-271150
K262030Aventus Thrombectomy SystemInquis Medical2026-07-15280
K260091Aventus Introducer SheathInquis Medical2026-04-13910
K253925Aventus Thrombectomy SystemInquis Medical2026-01-15380
K251189Aventus Thrombectomy SystemInquis Medical2025-06-13570
K250668Aventus Thrombectomy System (IM-2100)Inquis Medical2025-03-25200
K250202Aventus Thrombectomy SystemInquis Medical2025-02-26330
K240426Aventus Clot Management SystemInquis Medical2024-05-14910
K240117Aventus Thrombectomy System (IM-2001/IM-0002)Inquis Medical2024-03-15590
K232730Aventus Thrombectomy SystemInquis Medical2023-11-01550

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda