Atlas FDA

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

Walk Vascular, LLC — Predicate Candidate Screening

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

113 daysmedian FDA review time
299 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K213565JETi AIO Peripheral Thrombectomy SystemWalk Vascular, LLC2022-02-01840
K201998JETi AIO Peripheral Thrombectomy SystemWalk Vascular, LLC2020-11-171200
K192439JETi Peripheral Thrombectomy SystemWalk Vascular, LLC2019-12-09940
K183403JETi 88 Peripheral Thrombectomy SystemWalk Vascular, LLC2019-04-171310
K172000ClearLumen II Peripheral Thrombectomy SystemWalk Vascular, LLC2017-10-241130
K163051ClearLumen II Peripheral Thrombectomy SystemWalk Vascular, LLC2017-02-211120
K161786ClearLumen II Thrombectomy SystemWalk Vascular, LLC2016-10-181110
K140296CLEARLUMEN THROMBECTOMY SYSTEMWalk Vascular, LLC2014-12-022990
K120508CLEARLUMEN THROMBECTOMY SYSTEMWalk Vascular, LLC2012-11-072600

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