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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: MNW FDA class 2

    Analyzer, Body Composition

    Cardiovascular

    View full classification →

    The Body Composition Analyzer is a device used to measure and analyze body composition parameters such as fat mass, lean mass, and body water content, providing clinicians with important metabolic and physiological data. Classified as FDA Class 2 under 21 CFR 870.2770 in the Cardiovascular specialty, it requires 510(k) premarket notification. The product code is MNW, reviewed by the Gastroenterology and Urology panel.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Multi-parameter detector
    BODY COMPOSITION ANALYZER
    BIOSPACE BODY COMPOSITION ANALYZER
    ARIA WIFI SMART SCALE
    BODY FAT ANALYZER AND SCALE
    INBODY
    BIA / VITALITY ANALYZER
    PRECISION ONE LIFECARE; DETECTO; DETECTO
    TRANSTEK GLASS BODY FAT ANALYZER
    TRANSTEK BODY FAT ANALYZER
    SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514
    INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B)
    TRANSTEK GLASS BODY FAT ANALYZER
    BODY FAT SCALE MODEL SF-371
    WITHINGS, SMART BODY SCALE
    WI-FI BODY SCALE
    WI-FI BODY SCALE
    WEIGHT AND BODY FAT SCALE SHINE BS0105
    BODY ANALYSIS SCALE
    TRANSTEK
    HUIBAO BODY FAT SCALE
    INBODY
    BODY ANALYSIS SCALE, MODEL BG 17
    TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER;TRANSTEK GLASS BODY ANALYZER
    MODEL MC-180MA MULTI-FREQUENCY BODY COMPOSITION ANALYZER
    ELECTRO SENSOR -BODY COMPOSITION
    QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNIT
    MODIFICATION TO BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT
    STAYHEALTHY BODY COMPOSITION MONITOR-BCM
    INBODY, MODELS: 270, R20, R20B
    ELECTROFLUIDGRAPH
    BODY COMPOSITION ANALYZER, MODEL: IOI 353
    TANITA BODY COMPOSITION ANALYZER, MODEL SC-331
    SCALEMAN BODY FAT SCALES, MODEL: FS-148BW1 SERIES
    BODYSTAT 1500 BODY COMPOSITION MONITORING UNIT
    KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530
    OHMNISCAN NG
    SLIMMANAGER BODY COMPOSITION ANALYZER, MODELS N40 AND SM-300
    BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 205
    BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, XBIA 900
    BC (BODY COMPOSITION SOFTWARE)
    BIOSPACE BODY COMPOSITION ANALYZERS, MODEL INBODY 230
    INNERSCAN BODY COMPOSITION MONITOR, INNERSCAN SEGMENTAL BODY COMPOSITION MONITOR
    BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500
    BEAVERITE BODY FAT SCALES, MODELS 8901, 8903, 8905, 8909, 8911, 8915, 9563 AND 9568
    BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5
    DUTECK BODY COMPOSITION ANALYZER
    BC100 BODY COMPOSITION ANALYSIS SYSTEM
    IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7
    BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER

    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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