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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: DWJ FDA class 2

    System, Thermal Regulating

    Cardiovascular

    View full classification →

    The Thermal Regulating System is a cardiovascular device used to control patient body temperature by circulating temperature-controlled water through a blanket or pad in contact with the patient, applied in surgical, intensive care, or cardiac procedure settings. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DWJ and it is regulated under 21 CFR 870.5900 within the Cardiovascular medical specialty. If the device is reusable, validated reprocessing instructions and reprocessing validation data must be included in the 510(k) submission (82 FR 26807). This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Celsi Warmer
    Arctic Sun Stat Temperature Management System
    HotDog Warming Mattress + Return Electrode
    Cocoon Convective Warming System, Model CWS7000
    Medline ComfortTemp Patient Warming System
    FilteredFlo Warming Blankets
    The IQoolTM System
    Barrier EasyWarm Active Self-Warming Blanket
    IOB Temperature Management System
    HotDog Warming Mattress + Return Electrode
    IOB Warming Blankets
    HotDog Temperature Management System
    3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation
    3M Bair Hugger Temperature Management System (Model 675)
    NOVA Patient Warming System
    HotDog Temperature Management Controller
    Astopad Patient Warming System
    STERIS Patient Warming System
    Arctic Sun Stat Temperature Management System
    IOB Warming Blankets
    Cocoon Convective Warming System
    Altrix Precision Temperature Management System
    Level 1 Convective Warmer
    The IQoolTM Warm System
    3M Bair Hugger Model 675 Total Temperature Management System
    Altrix Temperature Management Wraps
    Mistral-Air Warming Unit
    IOB Temperature Management System
    OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY
    Altrix Precision Temperature Management System
    Arctic Sun Temperature Management System
    Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad
    TECOTHERM NEO (T NEO)
    EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING BLANKET, SNUGGLE WARM PEDIATRICFULL BODY
    COCOON CONVECTIVE WARMING SYSTEM
    BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET
    VITAHEAT PATIENT WARMING SYSTEM
    WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET
    COVIDIEN WARMTOUCH CONVECTIVE WARMING UNIT
    WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS
    PINTLER PATIENT WARMING SYSTEM
    WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEM
    HYBRID ARCTICGEL PAD
    WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS)
    NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS
    HOTDOG PATIENT WARMING SYSTEM
    SIROCCO THERMAL REGULATING SYSTEM
    BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM
    MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900
    CRITICOOL PRO

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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