Atlas FDA

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

NGE — Predicate Candidate Screening

6 FDA 510(k) clearances under this product code; the 50 most recent screened below.

90 daysmedian FDA review time
209 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K020808FERTILITE OVPheromone Sciences Corp.2002-09-231950
K990223MODIFICATION OF CLEARPLAN EASY FERTILITY MONITORUnipath , Ltd.1999-02-24300
K981207CLEARPLAN EASY FERTILITY MONITORUnipath , Ltd.1998-10-282090
K973860OVULON MONITORConception Technology, Inc.1998-01-07900
K863121PEAK OVULATION PREDICTORMicron Technology, Inc.1986-10-14610
K850579CUE FERTILITY MONITORZetek, Inc.1985-03-22370

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