Atlas FDA

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

Pegavision Corporation — Predicate Candidate Screening

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

225 daysmedian FDA review time
254 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) CPegavision Corporation2026-05-212330
K261299Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic)Pegavision Corporation2026-05-19290
K252385Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic)Pegavision Corporation2026-03-132250
K251095Pegavision (Hioxifilcon A) Daily Disposable Soft Contact LenPegavision Corporation2025-09-171600
K243868Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic)Pegavision Corporation2025-07-021970
K232649Pegavision (Hioxifilcon A) Daily Disposable Soft Contact LenPegavision Corporation2024-05-082510
K222885Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) ContacPegavision Corporation2023-05-312500
K211603Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) CoPegavision Corporation2022-02-022540
K211448Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) CoPegavision Corporation2021-12-062100
K200296Pegavision (Etafilcon A) Color Daily Disposable Soft (HydropPegavision Corporation2020-10-152520
K161739Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Pegavision Corporation2016-12-191780
K140025AQUAMAX (ETAFILCON A) BI-WEEKLY DISPOSABLE SOFT (HYDROPHILICPegavision Corporation2014-10-152820
K123973AQUAMAX (POLYMACON) DISPOSABLE SOFT (HYDROPHILIC) CONTACT LEPegavision Corporation2013-04-231180
K120028AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSESPegavision Corporation2012-04-171040

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