Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
I-See Vision Technology, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K150293 | EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D), EZvu | I-See Vision Technology, Inc. | 2015-04-15 | 68 | 0 |
| K082879 | EZVUE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAIL | I-See Vision Technology, Inc. | 2009-06-16 | 260 | 0 |
| K082880 | EZVUE (OCUFILCON D) 1-DAY SOFT (HYDROPHILIC)CONTACT LENS | I-See Vision Technology, Inc. | 2009-06-16 | 260 | 0 |
| K082883 | EZVIEW (POLYMACON) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAIL | I-See Vision Technology, Inc. | 2009-06-16 | 260 | 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