Cleared Traditional

K111622 - UNIMAX ANTI-FOG SOLUTION

K111622 is an FDA 510(k) clearance for UNIMAX ANTI-FOG SOLUTION, manufactured by Unimax Medical Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OCT cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K111622 · Unimax Medical Systems, Inc. · Gastroenterology & Urology device
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Sep 2011
Decision
91d
Days
Class 2
Risk

K111622 is an FDA 510(k) clearance for the UNIMAX ANTI-FOG SOLUTION. Classified as Anti Fog Solution And Accessories, Endoscopy (product code OCT), Class II - Special Controls.

Submitted by Unimax Medical Systems, Inc. (Taipei County, TW). The FDA issued a Cleared decision on September 9, 2011 after a review of 91 days - within the typical 510(k) review window.

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 Unimax Medical Systems, Inc. devices

FDA 510(k) Submission Details - K111622

510(k) Number K111622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2011
Decision Date September 09, 2011
Days to Decision 91 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
39d faster than avg
Panel avg: 130d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OCT Device Classification - Class 2, Special Controls

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 9
Devices cleared under the same product code (OCT) and FDA review panel - the closest regulatory comparables to K111622.
Konix Anti-Fog Solution
K190864 · Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler · Aug 2020
AMD Anti-Fog Solution
K181887 · Advanced Medical Design Co., Ltd. · Jan 2019
Medline Anti-Fog Solution
K152948 · Medline Industries, Inc. · Feb 2016
DEROYAL INDUSTRIES, INC. DEFOGGER
K982465 · Deroyal Industries, Inc. · Aug 1998
U.C.E.Z. LENS CLEANER KIT
K925659 · Anago, Inc. · Sep 1993
DR. FOG
K932449 · O.R. Concepts, Inc. · Aug 1993