Atlas FDA

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

Visco Vision, Inc. · Predicate Candidate Screening

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

131 daysmedian FDA review time
273 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K200618HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Visco Vision, Inc.2020-12-072730
K201080Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel SofVisco Vision, Inc.2020-07-15840
K191397OxySoft (olifilcon C) silicone hydrogel soft contact lensVisco Vision, Inc.2019-10-021310
K183670Vexillum Zephyr (olifilcon A) with Tangible Polymers SphericVisco Vision, Inc.2019-09-132600
K181349Vexillum (olifilcon B) with Tangible Polymers Silicone HydroVisco Vision, Inc.2018-09-191210
K180322Si-Hy (olifilcon B) color silicone hydrogel soft contact lenVisco Vision, Inc.2018-04-20740
K173958OxyAqua (olifilcon D) spherical silicone hydrogel soft contaVisco Vision, Inc.2018-04-03960
K171447OxyPure Color Silicone Hydrogel Soft Contact LensesVisco Vision, Inc.2017-12-052030
K160245Visco (olifilcon A) soft contact lensVisco Vision, Inc.2016-10-242660
K160344Si-Hy (olifilcon B) sperical silicone hydrogel soft contact Visco Vision, Inc.2016-05-261080
K141348VISCO SOFT CONTACT LENSVisco Vision, Inc.2015-06-223960

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