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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: BZH FDA class 2

    Meter, Peak Flow, Spirometry

    Anesthesiology

    View full classification →

    The Meter, Peak Flow, Spirometry is a portable or clinical device used to measure peak expiratory flow rate, providing a simple and rapid assessment of large airway obstruction useful in managing asthma and other obstructive lung conditions. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BZH, regulated under 21 CFR 868.1860 in the Anesthesiology specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Peak Flow Meter
    Aluna 2
    Electronic Peak Flow Meter
    TD-7301 Peak Flow meter
    Peak flow meter
    Safey Peak Flow Meter
    Aluna
    Smart Peak Flow Meter
    Peak.me
    Smart One
    Besmed Peak Flow Meter
    MSA100BT Peak Flow Meter
    Wing Smart FEVI and Peak Flow Meter
    MSA100 PEAK FLOW METER
    STRIVE DUAL ZONE PEAK FLOW METER
    RXPEAKFLOW
    PEAK EXPIRATORY FLOW METER, KN-9710
    CLEAN PEAK FLOW METER
    DYNAMIPEAK PEAK FLOW METER
    MINI-WRIGHT DIGITAL, MODEL 3120001
    PMP4 SPIROPRO
    MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH PEF AND FEV1, MODELS PF-100 AND PF-100-1 (WITH SOFTWARE)
    MICROLIFE ELECTRONIC PEAK FLOW MONITOR, MODEL PF-100
    MICROPEAK
    MODIFICATION TO TRUPEAK PEAK FLOW METER
    GALEMED PEAK FLOW METER, MODELS 3751/3752
    TRUEZONE PEAK FLOW METER
    KP + LFM
    KOKO PEAK KP; KOKO PEAK KP+
    ONEFLOW
    VITALOGRAPH MICRO
    RESPALERT
    MODIFICATION TO TRUZONE PEAK FLOW METER
    AIRZONE PEAK FLOWMETER
    ACCUTRAX, MODEL EPF840
    AIRWATCH II ZONE
    AIRWATCH II ZONELESS
    WHISTLE WATCH
    IN-CHECK INSPIRATORY FLOWMETER
    PEAK FLOW METER MINIMAX
    MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER
    PEAK FLOW METER
    AEROGEAR ASTHMA ACTION KIT
    VM PLUS PEAK FLOWMETER
    TRUZONE PEAK FLOW METER
    TRUPEAK PEAK FLOW METER
    PERSONAL BEST II WITH ZONE MANAGEMENT SYSTEM
    PERSONAL BEST II
    BREATH-TAKER BREATH-ALERT
    MINI WRIGHT LR AFS

    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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