Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FOK · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
30 daysmedian FDA review time
102 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K962290 | DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER | Debusk Technology Corp. | 1996-07-03 | 19 | 0 |
| K926118 | LIFE TRACE(R) BILIRUBIN MASK | Graphic Controls Corp. | 1993-03-15 | 102 | 0 |
| K851918 | INFANT PHOTOTHERAPY MASK | Alba Health Care | 1985-06-07 | 36 | 0 |
| K840894 | PHOTO-THERAPY EYE PROTECTOR | A & A Medical Supplies Co. | 1984-03-23 | 25 | 0 |
| K813214 | INFANT PHOTOTHERAPY MASK | Montrose Phototherapy Supply | 1981-12-09 | 30 | 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