Cleared Traditional

K122653 - MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES (FDA 510(k) Clearance)

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

K122653 · Kimberly Clark Corporation · Gastroenterology & Urology device

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Jun 2013

Decision

299d

Days

Class 2

Risk

K122653 is an FDA 510(k) clearance for the MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Kimberly Clark Corporation (Roswell, US). The FDA issued a Cleared decision on June 26, 2013 after a review of 299 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - 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.

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Submission Details

510(k) Number	K122653 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received	August 31, 2012
Decision Date	June 26, 2013
Days to Decision	299 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF
Third-party Review	Yes - reviewed by an FDA-accredited third party

Regulatory Context

Review time vs. panel average

169d slower than avg

Panel avg: 130d · This submission: 299d

Pathway characteristics

Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code	KNT Tubes, Gastrointestinal (and Accessories)
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 876.5980

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.