Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Advanced Reproductive Technologies — Predicate Candidate Screening

5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

292 daysmedian FDA review time
364 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K991380OIL FOR TISSUE CULTUREAdvanced Reproductive Technologies2000-04-193640
K991395QUINN'S HTF MEDIUM, QUINN'S HTF MEDIUM WITH HEPES, QUINN'S BAdvanced Reproductive Technologies2000-02-153000
K991392HUMAN SERUM ALBUMINAdvanced Reproductive Technologies2000-02-072920
K991379QUINN'S SPERM WASHING MEDIUMAdvanced Reproductive Technologies2000-02-022870
K991391PVP, POLYVINYLPYRROLIDONE 10% (W/V) IN HEPES-HTFAdvanced Reproductive Technologies2000-01-102640

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