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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: BTY FDA class 2

    Calculator, Predicted Values, Pulmonary Function

    Anesthesiology

    View full classification →

    The Calculator, Predicted Values, Pulmonary Function is a device or software tool used to calculate expected or normal pulmonary function values based on patient demographics such as age, height, sex, and ethnicity, serving as a reference for interpreting spirometry results. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BTY, regulated under 21 CFR 868.1890 in the Anesthesiology specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Ascent Cardiorespiratory Diagnostic Software
    SpiroSphere, SpiroSphereECG, CardioSphere
    Pulmonary Function Tester, Model: A9
    Virtus Metabolic Monitor
    Model 9100 PFT/DICO
    MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU
    Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors
    Ascent Cardiorespiratory Diagnostic Software
    SpiroSphere
    EasyOne Pro Respiratory Analysis System
    Shape-HF Cardiopulmonary Testing System
    SENTRYSUITE PRODUCT LINE
    EASYONE PRO RESPIRATORY TESTING DEVICE
    SENTRYSUITE PRODUCT LINE
    SENTRYSUITE PRODUCT LINE
    EASYONE PRO RESPIRATORY ANALYSIS SYSTEM
    SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM
    MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT
    VIP PULMONARY FUNCTION SYSTEM
    FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT
    MASTERSCREEN PNEUMO & MASTERSCOPE
    MODIFICATION TO FLOWSCREEN
    COSMED PONY FX
    SPIROSOFT
    COSMED MICROQUARK
    METALYZER, MODEL 2; METALYZER, MODEL 3
    SPIRO PRO
    STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX SERIES
    MODIFICATION TO THE OXYCONALPHA
    DSXL DIFFUSION SPIROMETER
    OXYCON-ALPHA
    VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS
    MASTER SCREEN PNUEMO
    FLOWSCREEN
    UPGRADED SPIROMETER ST-90
    MODEL 508 PATIENT MONITOR
    PFM PROFESSIONAL 7000 SPIROMETER
    VITALOGRAPH DATA STORAGE SPIROMETER
    CMD/DLCO DIAGNOSTIC SPIROMETER
    EBS2605 INFANT HUGGER
    MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP
    PULMONARY FORCED FLOW SYSTEM (PUFFS)
    UPDATED MANUAL FOR PEDS - PULMONARY EVAL. & DIAG.
    L.A.P. SPIROMETER
    PEDS PULMONARY EVALUATION & DIAGNOSTIC SYSTEM
    SPIROLOOP-PULMONARY EXERCISE SYSTEM
    ST-90 SPIRO ANALIZER
    SPIROMETRY MODULE
    SPIROMETER, MODEL TS-500 PART #SLZ7534
    SPIROMETER TS-400 SLZ 7547

    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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