Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gynex Corp. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
218 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K061306 | CO-1000 COLPOSCOPE, MULTIPLE | Gynex Corp. | 2006-08-07 | 89 | 0 |
| K982739 | GYNEX ELECTRODES | Gynex Corp. | 1999-03-12 | 218 | 0 |
| K980238 | GYNEX EXTENDED REACH NEEDLE | Gynex Corp. | 1998-08-21 | 210 | 0 |
| K980237 | GYNEX ENDOSPECULUM | Gynex Corp. | 1998-04-08 | 75 | 0 |
| K980247 | GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM | Gynex Corp. | 1998-03-17 | 53 | 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