Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Optical Connection, Inc. · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K051095 | 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DA | Optical Connection, Inc. | 2005-08-16 | 110 | 0 |
| K040900 | S-42 UV, T-42 UV TORIC AND M-42 UV MULTIFOCAL (HEFILCON A) S | Optical Connection, Inc. | 2004-06-15 | 70 | 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