510(k) Report

FDA applicant

Bacou USA, Inc. and Uvex Safety, Inc.

Mchenry, IL3 decisions1982–19920 recalls

FDA records 3 decisions for Bacou USA, Inc. and Uvex Safety, Inc. (Mchenry, IL) from 1982 to 1992: 3 510(k) clearances. Most are in product codes HQY (Sunglasses (Non-Prescription Including…) and HOI (Spectacle, Magnifying). 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, ophthalmic panel, where it files most

How often FDA has decided Bacou USA, Inc. and Uvex Safety, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bacou USA, Inc. and Uvex Safety, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bacou USA, Inc. and Uvex Safety, 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?

  • HQYSunglasses (Non-Prescription Including Photosensitive)2decisions
  • HOISpectacle, Magnifying1decision

What has FDA decided for it lately?

  • K920211Sun/SportglassesBacou USA, Inc. and Uvex Safety, Inc. · 1992
  • K820016Uvex Alpha, Beta, Gamma & Delta SunBacou USA, Inc. and Uvex Safety, Inc. · 1982
  • K813548Uvex Mini-SpecsBacou USA, Inc. and Uvex Safety, Inc. · 1982

All 3 as Bacou USA, Inc. and Uvex Safety, Inc. →