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

    Blood Volume Analyzer (200)

    K Number: K261099 · Decision Jun 18, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    2
    Applicant Total
    4
    Review Days
    77

    Basic Information

    Device Name
    Blood Volume Analyzer (200)
    K Number
    K261099
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    864.5950
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Daxor Corporation
    Date Received
    April 2, 2026
    Decision Date
    June 18, 2026
    Product Code
    JWO
    Advisory Committee
    Hematology
    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
    JWO Device, Blood Volume Measuring

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    Other Clearances by Daxor Corporation

    K Number Device Name
    K251087 Blood Volume Analyzer (200)
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