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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: FRW FDA class 1

    Scale, Patient

    General Hospital

    View full classification →

    A patient scale is a clinical weighing device used to measure a patient's body weight, supporting ongoing monitoring and medical decision-making in healthcare settings. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FRW, regulated under 21 CFR 880.2720, within the General Hospital medical specialty. No special flags apply to this device.

    510(k) Clearances

    48 matches
    K Number
    Device Name
    OLYMPIC SMART SCALE MODEL 50/50RA
    OLYMPIC SMART SCALE
    OLYMPIC SMART SCALE
    WARM-SCALE
    ADVANCED IN-BED WEIGH SYSTEM
    DIGITAL BABY SCALE MODEL BLB-12
    MODEL 9100 H.R. INFANT SCALE
    EZ PUMP
    3M MODEL 280RT RATE TAPER INFUSION PUMP
    3M MODEL 200RT RATE TAPER INFUSION PUMP
    SANITAS PATIENT SCALE
    DISETRONIC DOLOMAT PUMP
    DETECTO MODEL 6700 SERIES
    MODEL 5002 LIFT WEIGH-SCALE
    FAIRBANKS BABY SCALE
    ARJO CENTURY SCALES WITH REMOTE
    SCALE-TRONIX PLATFORM SCALE
    U.S. MEDICAL PS-1000 PEDIATRIC SCALE
    U.S. MEDICAL PS-3000 NEONATAL SCALE
    U.S. MEDICAL PS-2000 PEDIATRIC SCALE
    SENTRY SCALE
    APOLLO MOBILE SCALE
    SMART SCALE X-RAY PLATFORM
    SCALE-TRONIX INCUBATOR SCALE MODEL:4050/MODIFIED
    SCALE-TRONIX INCUBATOR SCALE MODEL:4050
    VAAKA BABY SCALE
    OLYMPIC SMART SCALE PEDIATRICS MODEL 50
    SAFEWEIGH MAGIC SCALE
    COMFORTWEIGH
    OLYMPIC SMART SCALE
    WARM WEIGH MODEL N-10 INFANT SCALE
    MODEL 304-S EXTERNAL MICRO-VOLUME INFUSION PUMP
    WEIGHMOBILE, IN BED PATIENT WEIGHING SCALE
    HOYER DIGITAL ELECTRONIC SCALE
    GRAM-MA NEONATAL SC
    ACME(BRAND) LOW-PROFILE WHEELCHAIR SCALE, 17400
    HEALTH-O-METER PHYSICIANS, DIGITAL ELEC SCALES
    ACME LOW-PROFILE CHAIR SCAL 7300
    ACME DIGITAL INFANT SCALE-30
    HAMILTON PEDIATRICS SCALE
    INFUSION PUMP ACCESS. #60-01-5
    DIGITAL BEDSIDE SCALE #5000
    SECA DIGITAL BABY SCALE 727
    SECA LIGHT WEIGHT BABY SCALE 744
    SECA CHAIR SCALE-721
    MODEL AS* 6C INFUSION PUMP
    SCALE, ACME DIGITAL BEDSIDE
    WEIGHING STATION, MOBILE PATIENT

    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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