Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Optacryl, 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) |
|---|---|---|---|---|---|
| K820817 | OPTACRY/95 GRAY CONTACT LENS BLANKS | Optacryl, Inc. | 1982-05-05 | 42 | 0 |
| K820815 | OPTACRY/95 BLUE CONTACT LENS BLANKS | Optacryl, Inc. | 1982-05-05 | 42 | 0 |
| K820816 | OPTACRY/ 95 GREEN CONTACT LENS BLANKS | Optacryl, Inc. | 1982-05-05 | 42 | 0 |
| K810130 | OPTOCRYL CONTACT LENS BLANKS | Optacryl, Inc. | 1981-06-11 | 143 | 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