Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Seiko Optical Products of America, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K942513 | SEIKO EYEGLASS FRAME | Seiko Optical Products of America, Inc. | 1994-07-15 | 50 | 0 |
| K900764 | SUNGLASS, NON-PRESCRIPTION | Seiko Optical Products of America, Inc. | 1990-06-20 | 120 | 0 |
| K873245 | AR DIACOAT SINGLE VISION LENSES | Seiko Optical Products of America, Inc. | 1987-10-05 | 49 | 0 |
| K861684 | SEIKO P-2 & SEIKO P-3 (SPECTACLE LENS) | Seiko Optical Products of America, Inc. | 1986-06-09 | 38 | 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