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

    Embryo Predict

    K Number: K250781 · Decision May 15, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    427

    Basic Information

    Device Name
    Embryo Predict
    K Number
    K250781
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6195
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alife Health
    Date Received
    March 14, 2025
    Decision Date
    May 15, 2026
    Product Code
    PBH
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PBH Embryo Image Assessment System, Assisted Reproduction

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