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

    Bayesian Health Sepsis Flagging Device

    K Number: K250680 · Decision Apr 30, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    420

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    Basic Information

    Device Name
    Bayesian Health Sepsis Flagging Device
    K Number
    K250680
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6316
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bayesian Health, Inc.
    Date Received
    March 6, 2025
    Decision Date
    April 30, 2026
    Product Code
    SAK
    Advisory Committee
    General Hospital
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    SAK Software Device To Aid In The Prediction Or Diagnosis Of Sepsis

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