Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QAJ · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
116 daysmedian FDA review time
414 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253285 | Elitone for Men | Elidah, Inc. | 2026-01-23 | 116 | 0 |
| K223884 | ELITONE Urge Urinary Incontinence Device | Elidah, Inc. | 2023-02-24 | 59 | 0 |
| K192357 | INNOVO | Atlantic Therapeutics, Ltd. | 2020-01-16 | 140 | 0 |
| K183585 | Elitone Device | Elidah, Inc. | 2019-02-11 | 52 | 0 |
| DEN170049 | Innovo | Bio-Medical Research, Ltd. | 2018-11-06 | 414 | 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