FDA applicant

Gentex Corporation

Mchenry, IL3 decisions1977–20090 recalls

FDA records 3 decisions for Gentex Corporation (Mchenry, IL) from 1977 to 2009: 3 510(k) clearances. Most are in product codes HQG (Lens, Spectacle, Non-Custom (Prescription)) and LGM (Chamber, Patient Isolation). 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 Gentex Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Gentex Corporation’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

Gentex Corporation

Which product codes does it file in?

What has FDA decided for it lately?