Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alcon Manufacturing, Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
161 daysmedian FDA review time
476 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K120912 | INFINITI(R) VISION SYSTEM | Alcon Manufacturing, Ltd. | 2012-06-15 | 81 | 1 |
| K112425 | INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HA | Alcon Manufacturing, Ltd. | 2011-11-21 | 90 | 0 |
| K101774 | MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MON | Alcon Manufacturing, Ltd. | 2011-10-13 | 476 | 0 |
| K101285 | CONSTELLATION VISION SYSTEM | Alcon Manufacturing, Ltd. | 2010-11-12 | 189 | 1 |
| K093210 | AQUALASE CAPSULE WASH TIP | Alcon Manufacturing, Ltd. | 2010-03-04 | 142 | 0 |
| K063155 | MONARCH III IOL DELIVERY SYSTEM | Alcon Manufacturing, Ltd. | 2007-03-27 | 161 | 1 |
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