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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: FMT FDA class 2

    Warmer, Infant Radiant

    General Hospital

    View full classification →

    The Infant Radiant Warmer is a device used in neonatal care that provides infrared radiant heat to maintain the body temperature of newborns, particularly premature or low-birth-weight infants, during examination and stabilization. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FMT, regulated under 21 CFR 880.5130 in the General Hospital specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Babyroo TN300
    Babyroo TN300
    Giraffe Omnibed Carestation CS1
    Panda iRes Warmer, Giraffe Warmer
    HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable
    Hydro-Temp Neonatal Skin Temperature Probe Cover
    NuBorne Infant Warmer
    GIRAFFE AND PANDA WARMERS
    RESUSCITAIRE WITH AUTOBREATH
    GIRAFFE AND PANDA WARMERS
    LULLABY TM WARMER
    SUNFLOWER WARNER
    INFA WARMER I
    GIRAFFE AND PANDA WARMERS
    MODIFICATION TO: GIRAFFE AND PANDA WARMER
    MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)
    GIRAFFE AND PANDA WARMER
    V-505 INFA WARMER
    PHOENIX INFANT RADIANT WARMER, MODEL 100NWS
    RPI REPLACEMENT HEATING ELEMENTS
    RPI SKIN OR AIR TEMPERATURE PROBE
    SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WC
    RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER
    ATOM INFA WARMER V-505
    INCUWARMER
    SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW970
    BABYTHERM 8004 BABYTHERM 8010
    ACCUTEMP-PROBE
    SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER
    SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT INFANT WARMER(IW990)
    INFANT RADIANT WARMER - MODELS IW910 AND IW920
    STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D)
    KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4)
    FIRST TOUCH DISPOSABLES TEMPERATURE PROBES
    INFANT WARMER SYSTEM
    ACCUTEMP PROBE
    TEMPERATURE PROBE-TP450
    TEMPERATURE PROBE-TP550
    TEMPERATURE PROBE-TP350
    TEMPERATURE PROBE-TP650
    TEMPERATURE PROBE-TP250
    TEMPERATURE PROBE-TP150
    DRAGER INFANT RADIANT WARMERN RH600
    ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE
    ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE
    RW RESUCITAIRE INFANT RADIANT WARMER
    DISPOSABLE TEMPERATURE PROBE COVER
    STABILET
    U. S. MEDICAL PS-3500 WARMER/INCUBATOR SCALE
    4002 INFANT SCALE FOR INCUBATORS AND WARMERS

    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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