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

    AquaC UNO H

    K Number: K250471 · Decision Nov 14, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    116
    Applicant Total
    51
    Review Days
    269

    Basic Information

    Device Name
    AquaC UNO H
    K Number
    K250471
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5665
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fresenius Medical Care Renal Therapies Group, LLC
    Date Received
    February 18, 2025
    Decision Date
    November 14, 2025
    Product Code
    FIP
    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
    FIP Subsystem, Water Purification

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