Atlas FDA

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

Inari Medical — Predicate Candidate Screening

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

32 daysmedian FDA review time
181 days90th percentile
26clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K253323Protrieve SheathInari Medical2025-10-29290
K230912Artix BGInari Medical2023-05-02320
K223419Triever16 CurveInari Medical2023-03-231330
K223436Artix AXInari Medical2023-03-021080
K223000Artix BGInari Medical2023-01-111050
K220887Mini-ClotTriever Thrombectomy SystemInari Medical2022-08-041290
K221846Artix Ballon Guiding SheathInari Medical2022-07-11170
K213402Triever24, Triever20Inari Medical2022-05-232170
K220600Artix Thrombectomy DeviceInari Medical2022-03-25230
K210176FlowSaver Blood FilterInari Medical2021-07-221810
K210195Triever CathetersInari Medical2021-02-24300
K202345FlowTriever Retrieval/Aspiration SystemInari Medical2020-12-181220
K201541FlowTriever Retrieval/Aspiration SystemInari Medical2020-12-041780
K193462ClotTriever Thrombectomy SystemInari Medical2020-09-092680
K192332ClotTriever Thrombectormy System, ClotTriever Catheter, ClotInari Medical2019-09-20240
K191710FlowTriever Retrieval/Aspiration SystemInari Medical2019-09-05710
K192036ClotTriever Thrombectomy SystemInari Medical2019-08-29300
K191368FlowTriever Retrieval/Aspiration SystemInari Medical2019-06-17260
K183198FlowTriever Retrieval/Aspiration SystemInari Medical2018-12-17280
K182233FlowTriever Retrieval/Aspiration SystemInari Medical2018-10-15590
K182531ClotTriever Thrombectomy SystemInari Medical2018-10-10260
K181694FlowTriever Retrieval/Aspiration SystemInari Medical2018-07-27300
K173672FlowTriever Retrieval/Aspiration System, Aspiration Guide CaInari Medical2018-02-05670
K173470ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTInari Medical2017-12-04260
K162970FlowTriever Retrieval/Aspiration System, Aspiration Guide CaInari Medical2016-11-22290
K152097Retraction AspiratorInari Medical2015-08-25280

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