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

    multiFlux 130 (F00013123); multiFlux 160 (F00013124)

    K Number: K252459 · Decision Feb 10, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    343
    Applicant Total
    51
    Review Days
    189

    Basic Information

    Device Name
    multiFlux 130 (F00013123); multiFlux 160 (F00013124)
    K Number
    K252459
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5860
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fresenius Medical Care Renal Therapies Group, LLC
    Date Received
    August 5, 2025
    Decision Date
    February 10, 2026
    Product Code
    KDI
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

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