FDA applicant

Bt Medical Co., Inc.

Bridgeport, PA6 decisions1992–20030 recalls

FDA records 6 decisions for Bt Medical Co., Inc. (Bridgeport, PA) from 1992 to 2003: 6 510(k) clearances. Most are in product codes IPF (Stimulator, Muscle, Powered) and JAA (System, X-Ray, Fluoroscopic, Image-Intensified). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Bt Medical”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

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

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

FDA decisions per year

No FDA decision for Bt Medical Co., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Bt Medical Co., Inc.’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

Bt Medical Co., Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?