510(k) Report

FDA applicant

B C Medical, Ltd.

J3y 7p9, CA8 decisions1980–19950 recalls

FDA records 8 decisions for B C Medical, Ltd. (J3y 7p9, CA) from 1980 to 1995: 8 510(k) clearances. Most are in product codes KPX (Changer, Radiographic Film/Cassette) and IZI (System, X-Ray, Angiographic). 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, radiology panel, where it files most

How often FDA has decided B C Medical, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for B C Medical, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like B C Medical, Ltd.’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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