BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing

    K Number: K252355 · Decision Nov 26, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    12
    Applicant Total
    5
    Review Days
    120

    Basic Information

    Device Name
    K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing
    K Number
    K252355
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sb-Kawasumi Laboratories, Inc.
    Date Received
    July 29, 2025
    Decision Date
    November 26, 2025
    Product Code
    PTI
    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
    PTI Non-Coring (Huber) Needle

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    Other Clearances by Sb-Kawasumi Laboratories, Inc.

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