BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    G0 Blood Pressure Monitoring System (G0)

    K Number: K250415 · Decision Jul 2, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    420
    Registration Numbers
    420
    Same Product Code
    1186
    Applicant Total
    1
    Review Days
    139

    Basic Information

    Device Name
    G0 Blood Pressure Monitoring System (G0)
    K Number
    K250415
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aktiia SA
    Date Received
    February 13, 2025
    Decision Date
    July 2, 2025
    Product Code
    DXN
    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
    DXN System, Measurement, Blood-Pressure, Non-Invasive

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DXN), ordered by most recent decision date.

    Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+);

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Globalcare Blood Pressure Monitor (GUS610)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    KOROT Blood Pressure Monitor (KOROT P3 Accurate)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all