BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Female Culture Device; Male Culture Device; Transfer Device; Access Device

    K Number: K252899 · Decision Jun 2, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    2
    Review Days
    264

    Basic Information

    Device Name
    Female Culture Device; Male Culture Device; Transfer Device; Access Device
    K Number
    K252899
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zhejiang Kindly Medical Device Co., Ltd.
    Date Received
    September 11, 2025
    Decision Date
    June 2, 2026
    Product Code
    JKA
    Advisory Committee
    Clinical Chemistry
    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
    JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

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    Other Clearances by Zhejiang Kindly Medical Device Co., Ltd.

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