Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ovamed Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
697 daysmedian FDA review time
851 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K951946 | HYSTEROSYS FLEXIBLE HYSTEROCOPE | Ovamed Corp. | 1995-11-20 | 208 | 0 |
| K931534 | OVAMED INTRAUTERINE ACCESS CATHETER | Ovamed Corp. | 1995-07-28 | 851 | 0 |
| K931167 | OVAMED FALLOPIAN OSTIAL ACCESS CATHETER | Ovamed Corp. | 1995-06-22 | 836 | 0 |
| K943593 | SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM | Ovamed Corp. | 1995-03-22 | 240 | 0 |
| K931122 | OVAMED HSG CATHETER | Ovamed Corp. | 1995-01-30 | 697 | 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