Cleared Traditional

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 · General Hospital

Dec 2022

Decision

201d

Days

Class 2

Risk

About This 510(k) Submission

K221603 is an FDA 510(k) clearance for the 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?, a Pump, Infusion, Enteral (Class II — Special Controls, product code LZH), submitted by Cardinal Health, LLC (Waukegan, US). The FDA issued a Cleared decision on December 20, 2022, 201 days after receiving the submission on June 2, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number	K221603 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 02, 2022
Decision Date	December 20, 2022
Days to Decision	201 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF