Cleared Traditional

K143018 - Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore Connectors (FDA 510(k) Clearance)

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

K143018 · Covidien · Gastroenterology & Urology device
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Apr 2015
Decision
164d
Days
Class 2
Risk

K143018 is an FDA 510(k) clearance for the Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore Connectors. Classified as Gastrointestinal Tubes With Enteral Specific Connectors (product code PIF), Class II - Special Controls.

Submitted by Covidien (Mansfield, US). The FDA issued a Cleared decision on April 2, 2015 after a review of 164 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 K143018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2014
Decision Date April 02, 2015
Days to Decision 164 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
34d slower than avg
Panel avg: 130d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PIF Gastrointestinal Tubes With Enteral Specific Connectors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
Definition To Facilitate Enteral Specific Connections.
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 - PIF Gastrointestinal Tubes With Enteral Specific Connectors

All 49
Devices cleared under the same product code (PIF) and FDA review panel - the closest regulatory comparables to K143018.
Percutaneous Endoscopic Gastrostomy (PEG) Kit
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Extension Feeding Set with ENFit™ Connectors
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Disposable Enteral Feeding Sets
K240052 · Beijing L&Z Medical Technology Development Co., Ltd. · Jul 2024
Mobility+ Enteral Feeding System OTC
K233034 · Rockfield Medical · Apr 2024
ENFit to ENFit Extension Sets
K230326 · Vesco Medical · Nov 2023