Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Gynetics Medical Products NV · 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) |
|---|---|---|---|---|---|
| K041237 | ECHOSAMPLER | Gynetics Medical Products NV | 2004-09-08 | 120 | 0 |
| K013501 | IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 | Gynetics Medical Products NV | 2001-11-30 | 39 | 0 |
| K013536 | EMTRAC; DELPHIN; SEMTRAC 2000 SET | Gynetics Medical Products NV | 2001-11-30 | 38 | 0 |
| K013497 | FAS SET #4551 | Gynetics Medical Products NV | 2001-11-09 | 18 | 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