BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    EmbraceMini

    K Number: K252981 · Decision Dec 22, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    18
    Applicant Total
    8
    Review Days
    96

    Basic Information

    Device Name
    EmbraceMini
    K Number
    K252981
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5050
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Empatica S.r.l.
    Date Received
    September 17, 2025
    Decision Date
    December 22, 2025
    Product Code
    LEL
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LEL Device, Sleep Assessment

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    Other Clearances by Empatica S.r.l.

    K Number Device Name
    K250515 EpiMonitor
    K242737 Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal
    K232915 EpiMonitor
    K230457 Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal
    K221282 Empatica Health Monitoring Platform
    K181861 Embrace
    K172935 Embrace