510(k) Report

FDA applicant

United Medical Ent., Inc.

Grovetown, GA1 decision1996–19960 recalls

FDA records 1 decision for United Medical Ent., Inc. (Grovetown, GA) in 1996: 1 510(k) clearance. All are in product code FXX (Mask, 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 United Medical Ent., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for United Medical Ent., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like United Medical Ent., 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

Which product codes does it file in?

  • FXXMask, Surgical1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K955513Surgical Mask (Non-Sterile)United Medical Ent., Inc. · 19961cites it

What has FDA decided for it lately?

  • K955513Surgical Mask (Non-Sterile)United Medical Ent., Inc. · 1996

The one decision as United Medical Ent., Inc. →