Cleared Traditional

K181887 - AMD Anti-Fog Solution (FDA 510(k) Clearance)

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

K181887 · Advanced Medical Design Co., Ltd. · Gastroenterology & Urology device
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Jan 2019
Decision
193d
Days
Class 2
Risk

K181887 is an FDA 510(k) clearance for the AMD Anti-Fog Solution. Classified as Anti Fog Solution And Accessories, Endoscopy (product code OCT), Class II - Special Controls.

Submitted by Advanced Medical Design Co., Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on January 22, 2019 after a review of 193 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 Advanced Medical Design Co., Ltd. devices

Submission Details

510(k) Number K181887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2018
Decision Date January 22, 2019
Days to Decision 193 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
63d slower than avg
Panel avg: 130d · This submission: 193d
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.