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

K221603 is an FDA 510(k) premarket notification submitted by Cardinal Health, LLC for the device "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™". The FDA issued a decision of Substantially Equivalent on December 20, 2022. The device falls under product code LZH (Pump, Infusion, Enteral), a Class II device regulated under 21 CFR 880.5725. Cardinal Health, LLC has at least 10 other 510(k) clearances on record.

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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  • K120934 — PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN CONTE (May 23, 2012)
  • K111878 — PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES (September 29, 2011)
  • K110272 — STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAP (June 8, 2011)

Other clearances for product code LZH

  • K253558 — Luminoah FLOW™ Enteral Nutrition System (April 20, 2026)
  • K232205 — Vesco Q™ Enteral Feeding Pump; Vesco Q™ 500mL Bag Feed Set; Vesco Q™ 1000mL Bag (October 23, 2023)
  • K220230 — AMSure Enteral Feeding Pump (November 10, 2022)
  • K200051 — PUGGLE Enteral Feeding Pump and Feeding Set (September 25, 2020)
  • K153074 — Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangar (July 6, 2016)
  • K143263 — Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets (May 29, 2015)
  • K141479 — KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS (December 23, 2014)
  • 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)

FDA data resources