Cleared Traditional

K221603 - Kangaroo OMNI™ Enteral Feeding Pump (385400 ) (FDA 510(k) Clearance)

Also includes:
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™

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K221603 · Cardinal Health, LLC · General Hospital
Download Printable Device Report (PDF)
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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

Submission Details

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
73d slower than avg
Panel avg: 128d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.