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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: BZT FDA class 2

    Stethoscope, Esophageal, With Electrical Conductors

    Anesthesiology

    View full classification →

    The Stethoscope, Esophageal, with Electrical Conductors is a stethoscope probe designed for insertion into the esophagus to monitor heart and breath sounds from inside the thorax during surgery or anesthesia, with integrated electrical conductors that may serve additional monitoring functions such as temperature measurement. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BZT, regulated under 21 CFR 868.1920 in the Anesthesiology specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    45 matches
    K Number
    Device Name
    Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French
    ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE
    ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR
    ESOPHAGEAL STETHOSCOPE
    ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR
    LIFESOUND ESOPHAGEAL STETHOSCOPE
    ESOPHAGEAL STETHOSCOPE
    DISPOSABLE ESOPHAGEAL STETHOSCOPE
    ARISTO ESOPHAGEAL STETHOSCOPE
    INTROSCOPE
    ESOPHAGEAL STETHOSCOPE
    DISPOSABLE ESOPHAGEAL STETHOSCOPE
    DEBUSK TEMPERATURE SYSTEMS PREMIER AND SIGNATURE SERIES MULTI-PURPOSE ESOPHAGEAL STETHOSCOPE
    DEBUSK TEMP. SYST. ESOPHAGEAL STETHOSCOPE
    BNOS MICROVENT(TM), MODEL AC AND MODEL AO
    YSI MODEL 441A AIRWAY TEMPERATURE PROBE
    TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE
    T-SCOPE, TELEMETRIC PRECORDIAL STETHOSCOPE
    YSI MODELS 4400 & 4700 ESOPHAGEAL STETHOSCOPE TEMP
    VITACOMM MODEL #140/141 ESOPHAGEAL STETHOSCOPE
    TELEMETRIC STETHOSCOPE
    SHERIDAN ELECTROSURGERY PROTECTION FILTER
    ESOPHAGEAL STETHOSCOPE W/ELECTRICAL CONDUCTORS
    ESOPHAGEAL STETHOSCOPE W/THERMISTOR
    MODIFIED TRACHEAL TUBE WITH SALTZMAN E.A.R.(TM)
    LIFESOUND(TM) ESOPHAGEAL STETHOSCOPE W/THERMISTOR
    ESOPHAGEAL STETHOSCOPE W/THERMOCOUPLE TYPE T
    ESOPHAGEAL STETHOSCOPE WITH THERMISTOR
    TEMPERATURE SENSING ESOPHAGEAL TRANSDUCER
    SALTZMAN EAR(TM) ENDOTRACHEAL ASCULTATION RECEPTOR
    SHERIDAN - YSI/ECG SONATEMP (TM)
    ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR
    ESOPHAGEAL STETHOSCOPE WITH ELECTRICAL CONDUCTORS
    ESOPHAGEAL STETHO SCOPE
    ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR
    VITACOMM 100 ESOPHAGEAL STETHOSCOPE
    SHERIDAN YSI/SONATEMP
    CARDIO-ESOPHASCOPE
    MODEL 40-80-2 DISPOS. ESOPHAGEAL STETHO
    CRITIKON #817 ESOPHAGEAL MULTI-PROBE
    ARGYLE ACC-U-THERM W/TEMPERATURE PROBE
    LIFESOUND ESOPHAGEAL STETHOSCOPE
    HI-LO TEMP ESOPHAGEAL STETHOSCOPE
    ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE
    STETHOSCOPE WITH TEMPERATURE SENSOR

    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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