Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MOE — Predicate Candidate Screening
19 FDA 510(k) clearances under this product code; the 50 most recent screened below.
87 daysmedian FDA review time
296 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K944872 | BIO-COR COLLAGEN CORNEAL SHIELD | Bausch & Lomb Healthcare and Optics Worldwide | 1995-07-26 | 296 | 0 |
| K915861 | MEDILENS-CS CORNEAL SHIELD | Chiron Ophthalmics | 1992-03-06 | 66 | 0 |
| K914529 | SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDS | Oasis Medical, Inc. | 1991-11-13 | 33 | 0 |
| K913148 | COLLAGEN SHIELD FOR ACUTE CARE | Vitaphore Corp. | 1991-10-15 | 91 | 0 |
| K905825 | COLLAGEN SHIELD, VARIOUS MODELS | Chiron Ophthalmics | 1991-06-10 | 161 | 0 |
| K902558 | COLLAGEN SHIELD FOR ACUTE CARE | Vitaphore Corp. | 1990-08-17 | 67 | 0 |
| K901880 | MEDILENS(TM) CORNEAL SHIELD | Chiron Ophthalmics | 1990-07-02 | 67 | 0 |
| K896449 | IM COLLAGEN SHIELD | Intermedical, Inc. | 1990-05-24 | 196 | 0 |
| K884962 | ADDIT. INDICATIONS FOR BIO-COR EXT COLLAGEN CORNEA | Bausch & Lomb Pharmaceutical, Inc. | 1990-02-09 | 448 | 0 |
| K885015 | COI 72 HR COLLAGEN SHIELD | Chiron Ophthalmics | 1989-06-23 | 200 | 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 |
| K885016 | COI 24 HR COLLAGEN SHIELD | Chiron Ophthalmics | 1989-02-01 | 58 | 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 |
| K882762 | COLLAGEN SHIELD | Chiron Ophthalmics | 1988-09-12 | 68 | 0 |
| K874224 | BIO-COR II COLLAGEN CORNEAL SHIELD | Bausch & Lomb, Inc. | 1988-01-22 | 98 | 0 |
| K874225 | BIO-COR EXT COLLAGEN CORNEAL SHIELD | Bausch & Lomb, Inc. | 1988-01-22 | 98 | 0 |
| K862315 | FYODOROV COLLAGEN CORNEAL SHIELD | Medical Technology Development Corp. | 1987-01-07 | 203 | 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