Cleared Traditional

K143263 - Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets

K143263 is an FDA 510(k) clearance for Kangaroo Connect Enteral Feeding Pump w..., manufactured by Covidien. The device is a Class 2 General Hospital device with product code LZH cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K143263 · Covidien · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
197d
Days
Class 2
Risk

K143263 is an FDA 510(k) clearance for the Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets. Classified as Pump, Infusion, Enteral (product code LZH), Class II - Special Controls.

Submitted by Covidien (Mansfield, US). The FDA issued a Cleared decision on May 29, 2015 after a review of 197 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Covidien devices

FDA 510(k) Submission Details - K143263

510(k) Number K143263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2014
Decision Date May 29, 2015
Days to Decision 197 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 129d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZH Device Classification - Class 2, Special Controls

Product Code LZH Pump, Infusion, Enteral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 General Hospital devices follow this clearance model.

Regulatory Peers - LZH Pump, Infusion, Enteral

All 15
Devices cleared under the same product code (LZH) and FDA review panel - the closest regulatory comparables to K143263.
AMSure Enteral Feeding Pump
K220230 · Amsino International, Inc. · Nov 2022
PUGGLE Enteral Feeding Pump and Feeding Set
K200051 · Amsino International, Inc. · Sep 2020
Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal
K153074 · Covidien · Jul 2016
KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS
K141479 · Covidien · Dec 2014
MEDI-SIS SYRINGE INFUSION SYSTEM
K111381 · Acacia, Inc. · Jan 2012
KANGAROO(R) 524 ENTERAL FEEDING PUMP AND ADMINISTRATION SETS
K945964 · Sherwood Medical Co. · Mar 1995