Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vistakon · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
51 daysmedian FDA review time
85 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K042275 | VISTAKON (SENOFILCON A) SOFT CONTACT LENS | Vistakon | 2004-10-28 | 66 | 1 |
| K033969 | ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONT | Vistakon | 2004-02-04 | 44 | 0 |
| K013973 | ACUVUE BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES | Vistakon | 2002-02-26 | 85 | 0 |
| K010507 | VISTAKON (METHAFILCON A) CONTACT LENSES | Vistakon | 2001-04-12 | 50 | 0 |
| K010218 | VISTAKON (HEFILCON C) CONTACT LENSES | Vistakon | 2001-03-16 | 51 | 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