Atlas FDA

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

Lucas Medical, Inc. — Predicate Candidate Screening

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

130 daysmedian FDA review time
275 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K983802LMI CAROTID ENDARTERECTOMY SHUNT CATHETER, MODEL #'S CES, CELucas Medical, Inc.1999-07-302750
K972623LMI IRRIGATION CATHETER (IGR)Lucas Medical, Inc.1997-11-191280
K970657LMI THROMBECTOMY CATHETERLucas Medical, Inc.1997-07-011300
K955126LMI BILIARY CATHETERLucas Medical, Inc.1996-05-101830
K954760LMI ARTERIAL EMBOLECTOMY CATHETERLucas Medical, Inc.1996-04-111770
K955125LMI OCCLUSION CATHETERLucas Medical, Inc.1996-03-111230
K955499LMI BILUMEN IRRIGATION ARTERIAL EMBOLECTOMY CAHTETERLucas Medical, Inc.1996-02-28890

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