Cleared Traditional

K123555 - KANGAROO FEEDING TUBES WITH IRIS TECHNOLOGY

K123555 is an FDA 510(k) clearance for KANGAROO FEEDING TUBES WITH IRIS TECHNOLOGY, manufactured by Covidien. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 506-day FDA review.

K123555 · Covidien · Gastroenterology & Urology device
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Apr 2014
Decision
506d
Days
Class 2
Risk

K123555 is an FDA 510(k) clearance for the KANGAROO FEEDING TUBES WITH IRIS TECHNOLOGY. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Covidien (Mansfield, US). The FDA issued a Cleared decision on April 9, 2014 after a review of 506 days - an unusually long review period, suggesting complex equivalence evaluation.

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

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FDA 510(k) Submission Details - K123555

510(k) Number K123555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2012
Decision Date April 09, 2014
Days to Decision 506 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
375d slower than avg
Panel avg: 131d · This submission: 506d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - KNT Tubes, Gastrointestinal (and Accessories)

All 398
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K123555.
AQUARIUS EXTENSION FEEDING SET
K141631 · Degania Silicone , Ltd. · Jul 2014
AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE
K132686 · Degania Silicone , Ltd. · May 2014
BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM
K133251 · C.R. Bard, Inc. · May 2014
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
LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON
K122030 · Degania Silicone , Ltd. · Sep 2012