Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gentex Corporation — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K080117 | PATIENT ISOLATION UNIT, MODEL G019-1000 | Gentex Corporation | 2009-01-30 | 379 | 0 |
| K800521 | THE LENS OR OMMI-GARD | Gentex Corporation | 1980-03-12 | 6 | 0 |
| K772024 | RX LENS SERIES | Gentex Corporation | 1977-11-09 | 14 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda