Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Biocompatibles Eyewear, 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) |
|---|---|---|---|---|---|
| K974408 | PROCLEAR (OMAFILCON A) DAILY WEAR CONTACT LENS | Biocompatibles Eyewear, Inc. | 1998-04-16 | 143 | 0 |
| K980218 | METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Biocompatibles Eyewear, Inc. | 1998-03-23 | 66 | 0 |
| K970095 | PROCLEAR COMPATIBLES DAILY WEAR CONTACT LENS | Biocompatibles Eyewear, Inc. | 1997-04-03 | 83 | 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