Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NBV · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K043480 | ENHANCE CLITORAL STIMULATION AID | Gynavations, Inc. | 2005-06-08 | 174 | 0 |
| K001576 | EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPY | Prosurg, Inc. | 2000-12-28 | 220 | 0 |
| DEN000006 | EROS-CLITORAL THERAPY DEVICE (CTD) | Urometrics, Inc. | 2000-04-28 | 1 | 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