BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    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™

    K Number: K221603 · Decision Dec 20, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    33
    Applicant Total
    2
    Review Days
    201

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    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™
    K Number
    K221603
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardinal Health, LLC
    Date Received
    June 2, 2022
    Decision Date
    December 20, 2022
    Product Code
    LZH
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LZH Pump, Infusion, Enteral

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LZH), ordered by most recent decision date.

    Luminoah FLOW™ Enteral Nutrition System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Vesco Q™ Enteral Feeding Pump; Vesco Q™ 500mL Bag Feed Set; Vesco Q™ 1000mL Bag Feed Set; Vesco Q™ 40mm Screw Cap Feed Set; Vesco Q™ ENPlus Feed Set

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AMSure Enteral Feeding Pump

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PUGGLE Enteral Feeding Pump and Feeding Set

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Cardinal Health, LLC

    K Number Device Name
    K211765 Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown