Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gynemetrics, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K811568 | CERVICAL DILATOR | Gynemetrics, Inc. | 1981-07-16 | 42 | 0 |
| K803210 | MENSTRUAL ASPIRATION KITS | Gynemetrics, Inc. | 1981-01-28 | 41 | 0 |
| K802315 | UTERINE SOUND | Gynemetrics, Inc. | 1981-01-12 | 111 | 0 |
| K802313 | UTERINE CURETTE | Gynemetrics, Inc. | 1981-01-12 | 111 | 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