Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Chiron Ophthalmics — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
123 daysmedian FDA review time
212 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K915861 | MEDILENS-CS CORNEAL SHIELD | Chiron Ophthalmics | 1992-03-06 | 66 | 0 |
| K914311 | CHIROFLEX II LENS MICROSERT(TM) | Chiron Ophthalmics | 1992-01-27 | 123 | 0 |
| K905825 | COLLAGEN SHIELD, VARIOUS MODELS | Chiron Ophthalmics | 1991-06-10 | 161 | 0 |
| K903575 | CHIROFLEX FORCEPS | Chiron Ophthalmics | 1990-12-21 | 135 | 0 |
| K903574 | CHIROFLEX LENS MICROSERT | Chiron Ophthalmics | 1990-09-17 | 40 | 0 |
| K901880 | MEDILENS(TM) CORNEAL SHIELD | Chiron Ophthalmics | 1990-07-02 | 67 | 0 |
| K894162 | OPTISOL | Chiron Ophthalmics | 1990-01-12 | 212 | 0 |
| K885015 | COI 72 HR COLLAGEN SHIELD | Chiron Ophthalmics | 1989-06-23 | 200 | 0 |
| K885016 | COI 24 HR COLLAGEN SHIELD | Chiron Ophthalmics | 1989-02-01 | 58 | 0 |
| K882762 | COLLAGEN SHIELD | Chiron Ophthalmics | 1988-09-12 | 68 | 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