510(k) Report

FDA applicant

Medical Concepts, Inc.

Santa Barbara, CA5 decisions1980–20110 recalls

FDA records 5 decisions for Medical Concepts, Inc. (Santa Barbara, CA) from 1980 to 2011: 5 510(k) clearances. Most are in product codes FTS (Camera, Cine, Endoscopic, With Audio) and DSH (Recorder, Magnetic Tape, Medical). Its devices cite 3 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 and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Medical Concepts, 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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