510(k) Report

FDA applicant

Futuristic Medical Concepts, Inc.

Plano, TX1 decision1990–19900 recalls

FDA records 1 decision for Futuristic Medical Concepts, Inc. (Plano, TX) in 1990: 1 510(k) clearance. All are in product code FYA (Gown, Surgical). 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 Futuristic Medical Concepts, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Futuristic Medical Concepts, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Futuristic”

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