510(k) Report

FDA applicant

Universal Prosthetics, Inc.

Mchenry, IL3 decisions1981–19830 recalls

FDA records 3 decisions for Universal Prosthetics, Inc. (Mchenry, IL) from 1981 to 1983: 3 510(k) clearances. Most are in product codes EIG (Retractor, All Types) and KAC (Tube, Laryngectomy). 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, dental panel, where it files most

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

FDA decisions per year

No FDA decision for Universal Prosthetics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Universal Prosthetics, 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?

  • EIGRetractor, All Types1decision
  • KACTube, Laryngectomy1decision
  • KNTTubes, Gastrointestinal (And Accessories)1decision

What has FDA decided for it lately?

  • K832366Zoller Burned Lip ConformerUniversal Prosthetics, Inc. · 1983
  • K813132The Chicago GulletUniversal Prosthetics, Inc. · 1982
  • K811428Northwestern Voice Restoration KitUniversal Prosthetics, Inc. · 1981

All 3 as Universal Prosthetics, Inc. →