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

    DEKA Infusion System, DEKA Administration Set

    K Number: K242693 · Decision Oct 7, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    59
    Applicant Total
    1
    Review Days
    28

    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
    DEKA Infusion System, DEKA Administration Set
    K Number
    K242693
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Deka Research and Development Corporation
    Date Received
    September 9, 2024
    Decision Date
    October 7, 2024
    Product Code
    LDR
    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
    LDR Controller, Infusion, Intravascular, Electronic

    Similar 510(k) Clearances

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

    DEKA Infusion System, DEKA Administration Set

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Volumetric Infusion Controller

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PACER MODEL 100 INFUSION CONTROLLER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500

    FDA 510(k)
    FDA Class 2 ·General Hospital

    UNIVERSAL CONTROLLER, MODEL 100

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