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

    Hot Pink Pad Warming System

    K Number: K260903 · Decision Apr 16, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    157
    Applicant Total
    6
    Review Days
    29

    Basic Information

    Device Name
    Hot Pink Pad Warming System
    K Number
    K260903
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Xodus Medical, Inc.
    Date Received
    March 18, 2026
    Decision Date
    April 16, 2026
    Product Code
    DWJ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    Y

    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.

    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 Xodus Medical, Inc.

    K Number Device Name
    K182080 Scope Antifogging System
    K081647 ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPS
    K063587 XODUS MEDICAL ANTI-FOG SOLUTION
    K053433 CAUTERY TIP CLEANER, MODEL 30500
    K053321 LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER