Cleared Traditional

K163257 - VitreOx Anti-fog Solution (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K163257 · Sio2 Nanotech, LLC · Gastroenterology & Urology device
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May 2017
Decision
191d
Days
Class 2
Risk

K163257 is an FDA 510(k) clearance for the VitreOx Anti-fog Solution. Classified as Anti Fog Solution And Accessories, Endoscopy (product code OCT), Class II - Special Controls.

Submitted by Sio2 Nanotech, LLC (Phoenix, US). The FDA issued a Cleared decision on May 24, 2017 after a review of 191 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sio2 Nanotech, LLC devices

Submission Details

510(k) Number K163257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2016
Decision Date May 24, 2017
Days to Decision 191 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 130d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OCT Anti Fog Solution And Accessories, Endoscopy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Prevent, Reduce Or Eliminate Condensation (fog) On Endoscopic Lens.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - OCT Anti Fog Solution And Accessories, Endoscopy

All 26
Devices cleared under the same product code (OCT) and FDA review panel - the closest regulatory comparables to K163257.
KnoxFog Anti-fogging Device
K251068 · Uv One Hygienics, Inc. · Aug 2025
GOLFF Sterile Anti-Fog Solution
K231822 · Batrik Medical Manufacturing, Inc. · Feb 2024
E-Brik Visualization Assistant
K221293 · Jdi Surgical, Inc. · Jul 2022
Konix Anti-Fog Solution
K190864 · Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler · Aug 2020