BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    YUWELL® Electronic Blood Pressure Monitor (YE630CR)

    K Number: K252779 · Decision Mar 5, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    14
    Review Days
    184

    Basic Information

    Device Name
    YUWELL® Electronic Blood Pressure Monitor (YE630CR)
    K Number
    K252779
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
    Date Received
    September 2, 2025
    Decision Date
    March 5, 2026
    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.

    Wrist Blood Pressure Monitor (XW-05)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VicorderCS (VCS-SYS-1100)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Upper arm electronic blood pressure monitor (XB-01)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Blood Pressure Monitor (W06LT)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)

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

    Other Clearances by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

    K Number Device Name
    K253228 YUWELL® Electronic Blood Pressure Monitor (YE650AR)
    K252805 YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)
    K242736 Portable Oxygen Concentrator (Spirit-3)
    K250878 YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)
    K213825 Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A
    K221372 YUWELL Electronic Blood Pressure Monitor
    K212385 YUWELL Finger Pulse Oximeter
    K203583 YUWELL infrared ear thermometer: YHT101, YHT200
    K201864 YUWELL Infrared Thermometer
    K200939 Electronic Blood Pressure Monitor
    Search all 14 clearances from Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. →