Home / 510(k) Clearances / K221603

510(k) K221603

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™ by Cardinal Health, LLC — Product Code LZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2022
Date Received
June 2, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Enteral
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

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  • K153074 — Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangar (July 6, 2016)
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  • K131154 — ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG E (February 12, 2014)
  • K111381 — MEDI-SIS SYRINGE INFUSION SYSTEM (January 13, 2012)
  • K060316 — COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS (June 23, 2006)
  • K040957 — NOA III ENTERAL NUTRITION PUMP (May 21, 2004)