Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PBH — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
290 daysmedian FDA review time
651 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250781 | Embryo Predict | Alife Health | 2026-05-15 | 427 | 0 |
| K243851 | CHLOE BLAST | Fairtility , Ltd. | 2025-08-15 | 242 | 0 |
| K182798 | KIDScore D3 | Vitrolife A/S | 2019-07-19 | 290 | 0 |
| K142147 | EEVA SYSTEM | Auxogyn, Inc. | 2014-11-24 | 111 | 0 |
| DEN120015 | EEVA 2.0 | Auxogyn, Inc. | 2014-06-06 | 651 | 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