BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    Origin™

    K Number: K243965 · Decision Aug 21, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    241

    Basic Information

    Device Name
    Origin™
    K Number
    K243965
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1120
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nerv Technology Inc. (D.B.A.) Fluidai Medical
    Date Received
    December 23, 2024
    Decision Date
    August 21, 2025
    Product Code
    SFO
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    SFO Electrode Measurement, Drain Effluent Ph