Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Fertipro 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) |
|---|---|---|---|---|---|
| K242640 | FertiCult Flushing medium; FertiCult Flushing medium with ph | Fertipro NV | 2025-05-30 | 269 | 0 |
| K221547 | InActiv Blue | Fertipro NV | 2024-06-11 | 746 | 0 |
| K070135 | VITRIFREEZE MEDIUM; VITRITHAW MEDIUM | Fertipro NV | 2007-08-16 | 212 | 0 |
| K053494 | OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE | Fertipro NV | 2006-03-23 | 98 | 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