510(k) Report

FDA applicant

Lucas Medical, Inc.

Anaheim, CA7 decisions1996–19990 recalls

FDA records 7 decisions for Lucas Medical, Inc. (Anaheim, CA) from 1996 to 1999: 7 510(k) clearances. Most are in product codes DXE (Catheter, Embolectomy) and MJN (Catheter, Intravascular Occluding, Temporary). Its devices cite 1 predicate, 0 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, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Lucas Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Lucas Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Lucas Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Lucas Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Lucas”

FDA records each applicant name separately; these may or may not be the same firm.