Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Yorktowne Optical Co., Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
57 daysmedian FDA review time
97 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K935446 | VISUAL HEALTHSHIELDS | Yorktowne Optical Co., Inc. | 1994-02-17 | 97 | 0 |
| K904585 | POST MYDRIATIC SPECTACLES | Yorktowne Optical Co., Inc. | 1990-10-26 | 17 | 0 |
| K903721 | WRAP-AROUND INSTANT SUNGLASSES | Yorktowne Optical Co., Inc. | 1990-10-11 | 57 | 0 |
| K903719 | FLAT SLIP-IN SUNGLASSES | Yorktowne Optical Co., Inc. | 1990-10-11 | 57 | 0 |
| K903720 | FLAT FIT-IN SUNGLASSES | Yorktowne Optical Co., Inc. | 1990-10-11 | 57 | 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