Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alcon Universal, Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
81 daysmedian FDA review time
121 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K021143 | OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION | Alcon Universal, Ltd. | 2002-08-08 | 121 | 1 |
| K002589 | OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION | Alcon Universal, Ltd. | 2000-10-23 | 63 | 0 |
| K001214 | OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION | Alcon Universal, Ltd. | 2000-07-10 | 87 | 0 |
| K001235 | OPTI-FREE SUPRACLENS DAILY POTEIN REMOVER / RGP MULTI-PURPOS | Alcon Universal, Ltd. | 2000-07-03 | 77 | 0 |
| K000385 | OPTI-FREE EXPRESS LENS DROPS | Alcon Universal, Ltd. | 2000-04-28 | 81 | 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