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

    BloodSTOP iX Trauma Matrix (TM-iX-20)

    K Number: K253017 · Decision Apr 30, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    126
    Applicant Total
    4
    Review Days
    223

    Basic Information

    Device Name
    BloodSTOP iX Trauma Matrix (TM-iX-20)
    K Number
    K253017
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lifescience Plus, Inc.
    Date Received
    September 19, 2025
    Decision Date
    April 30, 2026
    Product Code
    QSY
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics

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    Other Clearances by Lifescience Plus, Inc.

    K Number Device Name
    K160130 BloodSTOP iX Battle Matrix
    K072681 BLOODSTOP HEMOSTATIC GAUZE; IX HEMOSTATIC GAUZE
    K071578 BLOODSTOP AND BLOODSTOP IX HEMOSTATIC GAUZE, MODELS BS-10,BS-11,BS-12,B-13, BS-IX27, BS-IX-14, BSIX-15, BSIX-17