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Kangaroo OMNI™ Enteral Feeding Pump (385400 ) +10 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K221603

by Cardinal Health, LLC

Identifiers

510(k) Number
K221603 FDA 510(k)
FDA Product Code
LZH FDA 510(k)
Models / Variants
Kangaroo OMNI™ Enteral Feeding Pump (385400 ) FDA 510(k)
Kangaroo OMNI™ Feeding Set 500ml (B5FD ) FDA 510(k)
Kangaroo OMNI™ ENtelliSet 500ml (E5FD ) FDA 510(k)
Kangaroo OMNI™ Feeding Set 1000ml (B10FD ) FDA 510(k)
Kangaroo OMNI™ ENtelliSet 1000ml (E10FD ) FDA 510(k)
Kangaroo OMNI™ ENPlus Spike Set (BSPFD ) FDA 510(k)
Kangaroo OMNI™ ENtelliSet ENPlus Spike ( ESPFD ) FDA 510(k)
Kangaroo OMNI™ Feeding Set 500ml with Flush Bag ( B5FF) FDA 510(k)
Kangaroo OMNI™ ENtelliSet 500ml with Flush Bag (E5FF) FDA 510(k)
Kangaroo OMNI™ Feeding Set 1000ml with Flush Bag ( E10FF ) FDA 510(k)
Kangaroo OMNI™ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5725 FDA 510(k)
Regulation Number
880.5725 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Kangaroo OMNI™ Enteral Feeding Pump (385400 ) +10 more models by Cardinal Health, LLC — Class II — FDA_510K — listed in FDA 510(k) — 11 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cardinal Health, LLC

Sources (1)

  • FDA 510(k) K221603 24 fields · synced Jun 18, 2026