Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
EYF · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
99 daysmedian FDA review time
129 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K922785 | IRRIVAGE | Autovage | 1992-10-16 | 129 | 0 |
| K911407 | HARDING STERNAL SHIELD | Harding Medical Devices | 1991-07-05 | 98 | 0 |
| K910104 | ANTI-FOG DISPOSABLE IV INDUCTION COVER | Central Plastic, Inc. | 1991-04-12 | 99 | 0 |
| K904389 | SI-PRO | David F. Trungale | 1990-12-17 | 82 | 0 |
| K832908 | COMFEEL PROTECTIVE RINGS | Coloplast A/S | 1983-12-12 | 105 | 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