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

    Warming System

    K Number: K252861 · Decision Apr 7, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    157
    Applicant Total
    2
    Review Days
    210

    Basic Information

    Device Name
    Warming System
    K Number
    K252861
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hangzhou Tappa Medical Technology Co., Ltd.
    Date Received
    September 9, 2025
    Decision Date
    April 7, 2026
    Product Code
    DWJ
    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
    DWJ System, Thermal Regulating

    Similar 510(k) Clearances

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

    Hot Pink Pad Warming System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Arctic Sun Temperature Management System (Model 5000)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Celsi Warmer

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Arctic Sun Stat Temperature Management System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HotDog Warming Mattress + Return Electrode

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Cocoon Convective Warming System, Model CWS7000

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

    Other Clearances by Hangzhou Tappa Medical Technology Co., Ltd.

    K Number Device Name
    K251950 Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S)