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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: BZC FDA class 2

    Calculator, Pulmonary Function Data

    Anesthesiology

    View full classification →

    The Calculator, Pulmonary Function Data is a device or software tool that processes raw spirometric and respiratory measurements to derive and display calculated pulmonary function parameters for clinical assessment. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is BZC, regulated under 21 CFR 868.1880 in the Anesthesiology specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    STS
    Vyntus/SentrySuite Product Line
    Vyntus BODY
    Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART
    COSMED K5 Wearable Metabolic Technology
    MiniBox +
    Vyntus / SentrySuite Product Line
    VYNTUS/ SENTRYSUITE PRODUCT LINE
    PULMONE MINIBOX PFT TM
    LCI OPTION FOR INNOCOR
    MASTERSCREEN & OXYCON CPX
    ZAN LUNG-FUNCTION LAB
    MASTERSCREEN CPX AND OXYCON CPX
    OXYCON MOBILE
    INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400
    CORTEX METAMAX
    COSMED QUARK
    AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO
    OXYCON PRO
    COSMO PLUS WITH NICO, MODEL 8200
    CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MONITOR METEOR 100, CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MO
    INTELLIFLOW RESPIRATORY ANALYZER
    COSMED K4
    VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101
    BENCHMARK TRANSFER TEST
    THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS
    CO 2 SMO PLUS
    AUTOLINK BODY PLETHYSMOGRAPH
    TRANSFLOW TEST
    VENTRAK RMMS 1550
    ACKRAD ESOPHAGEAL BALLOON CATHETER SET
    DIRECTIONAL CONTROL VALVES INFLATABLE BALLOON-TYPE AND CONTROLLERS
    DX1-PORTABLE
    MMS-2400
    TEEN 100
    LUNG DIFFUSION
    LUNG DIFFUSION
    ARGIS PULMONARY FUNCTION TESTING SYSTEM
    SENSORMEDICS MODEL 2600 PEDIATRIC PULMOONARY CART
    MODEL 2900 METABOLIC MEASUREMENT CART
    MULTISPIRO-BREEZE
    SPIROSCOPE
    BIORE CP-100 CARDIOPULMONARY MONITOR
    MODIFIED STAR CALC
    PEDS WATER FILLED CATHETER/TRANSDUCER SYSTEM
    OS-1 OCCLUSION SYSTEM - 1
    PHYSIO-DYNE EASI (EASY ANALOG SAMPLING INTERFACE)
    SPIRO-LINK REAL TIME SPIROMETRY SYSTEM
    Q-PLEX 1
    ARGIS PULMONARY FUNCTION TESTING SYSTEM

    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.

    Popular Product Codes

    Commonly searched
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