BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇰🇷 South Korea

    SMART M-CELL Bone Marrow Concentration System

    K Number: K250518 · Decision Apr 2, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    405

    Basic Information

    Device Name
    SMART M-CELL Bone Marrow Concentration System
    K Number
    K250518
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2050
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Miracell Co., Ltd.
    Date Received
    February 21, 2025
    Decision Date
    April 2, 2026
    Product Code
    QBV
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QBV Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate

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    Other Clearances by Miracell Co., Ltd.

    K Number Device Name
    K250516 SMART M-CELL PRP Concentration System