Cleared Traditional

Konix Anti-Fog Solution (K190864) - FDA 510(k) Clearance

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

K190864 · Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler · Gastroenterology & Urology device
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Aug 2020
Decision
512d
Days
Class 2
Risk

K190864 is an FDA 510(k) clearance for the Konix Anti-Fog Solution. Classified as Anti Fog Solution And Accessories, Endoscopy (product code OCT), Class II - Special Controls.

Submitted by Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler (Istanbul, TR). The FDA issued a Cleared decision on August 27, 2020 after a review of 512 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler devices

Submission Details

510(k) Number K190864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2019
Decision Date August 27, 2020
Days to Decision 512 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
382d slower than avg
Panel avg: 130d · This submission: 512d
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 Consultant

St&T Research, Inc.
Ronald J. Amen

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K190864.
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K221293 · Jdi Surgical, Inc. · Jul 2022
AMD Anti-Fog Solution
K181887 · Advanced Medical Design Co., Ltd. · Jan 2019