Cleared Traditional

K221603 - Kangaroo OMNI Enteral Feeding Pump (385...

Also marketed or referenced as:
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 is an FDA 510(k) clearance for Kangaroo OMNI Enteral Feeding Pump (385..., manufactured by Cardinal Health, LLC. The device is a Class 2 General Hospital device with product code LZH cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K221603 · Cardinal Health, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2022
Decision
201d
Days
Class 2
Risk

K221603 is an FDA 510(k) clearance for the Kangaroo OMNI™ Enteral Feeding Pump (385400 ). Classified as Pump, Infusion, Enteral (product code LZH), Class II - Special Controls.

Submitted by Cardinal Health, LLC (Waukegan, US). The FDA issued a Cleared decision on December 20, 2022 after a review of 201 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 Cardinal Health, LLC devices

FDA 510(k) Submission Details - K221603

510(k) Number K221603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 129d · This submission: 201d
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 11
Devices cleared under the same product code (LZH) and FDA review panel - the closest regulatory comparables to K221603.
Luminoah FLOW™ Enteral Nutrition System
K253558 · Luminoah · Apr 2026
Vesco Q™ Enteral Feeding Pump
K232205 · Vesco Medical, LLC · Oct 2023
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