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

    SmartSpectra Vital Signs Monitor 1.0

    K Number: K254169 · Decision Jun 18, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    12
    Applicant Total
    1
    Review Days
    177

    Basic Information

    Device Name
    SmartSpectra Vital Signs Monitor 1.0
    K Number
    K254169
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2785
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Presage Security, Inc. d/b/a Presage Technologies, Inc.
    Date Received
    December 23, 2025
    Decision Date
    June 18, 2026
    Product Code
    QME
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QME Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate

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