Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bausch & Lomb Pharmaceutical, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
448 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K884962 | ADDIT. INDICATIONS FOR BIO-COR EXT COLLAGEN CORNEA | Bausch & Lomb Pharmaceutical, Inc. | 1990-02-09 | 448 | 0 |
| K884960 | ADDIT. INDICATION FOR FYODOROV COLLAGEN CORNEAL | Bausch & Lomb Pharmaceutical, Inc. | 1989-02-13 | 87 | 0 |
| K884961 | ADDIT. INDICATIONS FOR BIO-COR II COLLAGEN CORNEAL | Bausch & Lomb Pharmaceutical, Inc. | 1989-02-13 | 87 | 0 |
| K884364 | LABELING CHANGES TO BIO-COR EXT COLLANGEN CORNEAL | Bausch & Lomb Pharmaceutical, Inc. | 1988-11-29 | 40 | 0 |
| K884363 | LABELING CHANGES TO BIO-COR II COLLANGEN CORNEAL | Bausch & Lomb Pharmaceutical, Inc. | 1988-11-29 | 40 | 0 |
| K884362 | LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD | Bausch & Lomb Pharmaceutical, Inc. | 1988-11-29 | 40 | 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