Cleared Traditional

K122653 - MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES

K122653 is an FDA 510(k) clearance for MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE..., manufactured by Kimberly Clark Corporation. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 299-day FDA review.

K122653 · Kimberly Clark Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Kimberly Clark Corporation devices

FDA 510(k) Submission Details - K122653

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
168d slower than avg
Panel avg: 131d · This submission: 299d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

KNT Device Classification - Class 2, Special Controls

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.

Regulatory Consultant

Underwriters Laboratories, Inc.
NED DEVINE

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 - KNT Tubes, Gastrointestinal (and Accessories)

All 515
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K122653.
ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE
K130611 · Xeridiem Medical Devices · Dec 2013
TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS)
K131052 · Actuated Medical, Inc. · Aug 2013
ELECTROMAGNETIC TRANSMITTING STYLET
K131532 · Corpak Medsystems · Aug 2013
AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KIT
K123716 · Applied Medical Technology, Inc. · Apr 2013
INSTAFLO BOWEL CATHETER SYSTEM KIT
K123804 · Hollister, Inc. · Apr 2013
BOEHRINGER GASTRIC SIZING TUBE
K130483 · Boehringer Laboratories, LLC · Mar 2013

FDA 510(k) Resources - Gastroenterology & Urology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.