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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: BZG FDA class 2

    Spirometer, Diagnostic

    Anesthesiology

    View full classification →

    The Spirometer, Diagnostic is a device used to measure lung volumes and airflow rates during forced or quiet breathing maneuvers, providing data for the diagnosis and monitoring of pulmonary conditions such as asthma, chronic obstructive pulmonary disease, and restrictive lung disease. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BZG, regulated under 21 CFR 868.1840 in the Anesthesiology specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    TD-7301 Spirometer (TD-7301)
    Air Next (NVD-02)
    Spirobank Oxi
    EasyOne Sky Spirometer
    Alveoair Digital Spirometer
    Air Smart Extra Spirometer
    SpiroHome Personal, SpiroHome Clinic
    ComPAS2
    Vitalograph Model 6000 Alpha
    Spirometer
    GoSpiro
    Spirotrac
    Safey Pocket Spirometer
    Vitalograph Model 2120 In2itive eDiary
    Air Next
    Asthma Monitor AM3
    Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option
    ComPAS2 (Computerized Pulmonary Analysis System)
    Pulmonx Chartis Tablet Console
    GoSpiro
    EasyOne Air Spirometer
    Q13 SPIROLYSER®
    SpiroScout
    Vitalograph Model 6300 micro
    IQSense Flow Sensor Mouthpiece
    Vitalograph Model 6600 Compact
    Vitalograph Model 6800 Pneumotrac
    MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DX
    SpiroThor
    PULMONE MINIBOXPFT 2.0
    MICROBLAB, MICROLOOP
    NeumoFilt Ergo/Neumo Filt BiteOn
    VITALOGRAPH MODEL 7000 SPIROTRAC
    MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO
    ASTHMA MONITOR AM3
    SPM-300
    SPIROTEL
    CCS-200 SPIROMETER
    MINISPIR
    ORBIT
    MICRO I
    SPIRODOC
    CHARTIS CONSOLE
    SPIRO PD
    ALERKAN SPIROMETRY FILTER
    MICRO DIARY SPIROMETER
    MASTERSCREEN IOS
    VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120
    ASTRASONIC SPIROMETER, MODEL 29-8000
    SPIROPALM

    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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