510(k) Report

FDA applicant

Barretta Products, Research and Development, Inc.

Mobile, AL1 decision1988–19880 recalls

FDA records 1 decision for Barretta Products, Research and Development, Inc. (Mobile, AL) in 1988: 1 510(k) clearance. All are in product code GAX (Tourniquet, Nonpneumatic). 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 Barretta Products, Research and Development, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Barretta Products, Research and Development, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • GAXTourniquet, Nonpneumatic1decision

What has FDA decided for it lately?

  • K881398TourniquetBarretta Products, Research and Development, Inc. · 1988

The one decision as Barretta Products, Research and Development, Inc. →