Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Optics Laboratory, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K161622 | LensGiene Sterile Saline Solution | Optics Laboratory, Inc. | 2016-08-11 | 59 | 0 |
| K110221 | EYE-CEPT STERILE SALINE SOLUTION | Optics Laboratory, Inc. | 2011-11-01 | 280 | 0 |
| K041008 | EYE-CEPT REWETTING DROPS | Optics Laboratory, Inc. | 2005-07-01 | 438 | 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