FDA applicant

Lucas Lifecare

Janesville, WI2 decisions2024–20250 recalls

FDA records 2 decisions for Lucas Lifecare (Janesville, WI) from 2024 to 2025: 2 510(k) clearances. Most are in product codes FLE (Sterilizer, Steam) and EHD (Unit, X-Ray, Extraoral With Timer). Its devices cite 2 predicates, 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, general hospital panel, where it files most

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

FDA decisions per year

1in 2025

2024high 1 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Lucas Lifecare by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Other applicant names beginning “Lucas”

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

Lucas Medical, Inc. 7 Lucas Grason-Stadler, Inc. 3 Lucas Sensing Systems, Inc. 1 Lucas & Rhea Mfg. 1

Lucas Lifecare

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Lucas”