Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gyneco, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
139 daysmedian FDA review time
244 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K861409 | SYNCARE TEMPORARY CARDIAC PACING WIRE | Gyneco, Inc. | 1986-05-05 | 20 | 0 |
| K853216 | MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4 | Gyneco, Inc. | 1986-04-02 | 244 | 0 |
| K852357 | GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP | Gyneco, Inc. | 1985-07-05 | 32 | 0 |
| K843941 | ENDOCYTE | Gyneco, Inc. | 1985-02-25 | 139 | 0 |
| K841275 | FINE NEEDLE ASPIRATION DEVICE | Gyneco, Inc. | 1984-08-17 | 143 | 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