Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Innova Vision, Inc. · Predicate Candidate Screening

11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

167 daysmedian FDA review time
300 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K240519Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Innova Vision, Inc.2024-04-17540
K232139Innova Vision (inifilcon A) Silicone Hydrogel Soft (HydrophiInnova Vision, Inc.2023-11-161210
K222954Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) ContInnova Vision, Inc.2023-03-131670
K213119Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) CoInnova Vision, Inc.2022-05-132280
K112373CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSInnova Vision, Inc.2012-08-173660
K083288DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH Innova Vision, Inc.2009-09-033000
K073060CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DInnova Vision, Inc.2007-11-29300
K062541CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENInnova Vision, Inc.2007-06-072810
K053191DISCON DAILY (ETAFILCON A) ONE-DAY SOFT (HYDROPHILIC) CONTACInnova Vision, Inc.2006-05-121780
K051129DISCON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAIInnova Vision, Inc.2005-08-121010
K033136I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2Innova Vision, Inc.2004-03-051570

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