Cleared Traditional

KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS

K141479 · Covidien · General Hospital
Dec 2014
Decision
202d
Days
Class 2
Risk

About This 510(k) Submission

K141479 is an FDA 510(k) clearance for the KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS, a Pump, Infusion, Enteral (Class II — Special Controls, product code LZH), submitted by Covidien (Mansfield, US). The FDA issued a Cleared decision on December 23, 2014, 202 days after receiving the submission on June 4, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K141479 FDA.gov
FDA Decision Cleared SESE
Date Received June 04, 2014
Decision Date December 23, 2014
Days to Decision 202 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LZH — Pump, Infusion, Enteral
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

Similar Devices — LZH Pump, Infusion, Enteral

All 32
Vesco Q? Enteral Feeding Pump; Vesco Q? 500mL Bag Feed Set; Vesco Q? 1000mL Bag Feed Set; Vesco Q? 40mm Screw Cap Feed Set; Vesco Q? ENPlus Feed Set
K232205 · Vesco Medical, LLC · Oct 2023
Kangaroo OMNI? Enteral Feeding Pump (385400 );Kangaroo OMNI? Feeding Set 500ml (B5FD );Kangaroo OMNI? ENtelliSet 500ml (E5FD );Kangaroo OMNI? Feeding Set 1000ml (B10FD );Kangaroo OMNI? ENtelliSet 1000ml (E10FD );Kangaroo OMNI? ENPlus Spike Set (BSPFD );Kangaroo OMNI? ENtelliSet ENPlus Spike ( ESPFD );Kangaroo OMNI? Feeding Set 500ml with Flush Bag ( B5FF);Kangaroo OMNI? ENtelliSet 500ml with Flush Bag (E5FF);Kangaroo OMNI? Feeding Set 1000ml with Flush Bag ( E10FF );Kangaroo OMNI?
K221603 · Cardinal Health, LLC · Dec 2022
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 Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets
K143263 · Covidien · May 2015