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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: DRS FDA class 2

    Transducer, Blood-Pressure, Extravascular

    Cardiovascular

    View full classification →

    The Extravascular Blood-Pressure Transducer is a cardiovascular measurement device used externally to convert pressure signals transmitted via fluid-filled tubing from an intravascular catheter into electrical signals for monitoring blood pressure. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DRS and it is regulated under 21 CFR 870.2850 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors
    Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes
    HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
    HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
    Compass Cast and MAP
    Disposable Pressure Transducer
    Flo Trac sensor, Volume View sensor
    Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel blood pressure system, IAP Monitoring Set with Disposable Transducer
    COMPASS CT, COMPASS CT PORT
    MEDLINE BLOOD PRESSURE TRANSDUCER
    ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)
    COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST
    COMBITRANS MONITORING SETS AND ACCESSORIES
    COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE
    REAVILLMED PRESSURE MONITORING SYSTEM AND PICC
    COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE
    TERUMO PRESSURE ISOLATOR
    DISPOSABLE PRESSURE TRANSDUCER
    ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM
    TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT
    TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT
    DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT)
    VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P
    BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP
    BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX
    BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX
    MX960 REUSABLE PRESSURE TRANSDUCER
    PERCEPTOR COMPENSATOR MORSE MANIFOLD
    NOVATRANS II
    WRISTRECORDER PLUS CARDIAC EVENT RECORDING SYSTEM
    COBE PATIENT MONITORING PRODUCTS
    MERITRANS(TM) DISPOSABLE TRANSDUCER
    TAD MODEL #9655
    THE PERCEPTOR(TM) STAND ALONE TRANSDUCER
    SERIES 51 AND 53 DISPOSABLE PRESSURE TRANSDUCERS
    ADVANCE DISPOSABLE PRESSURE TRANSDUCER
    OSCILLOMETRIC PULSE DETECTION DEVICE
    MORSE DT MANIFOLD
    MATRX DISPOSABLE NON-INVASIVE GELLED PACING ELEC.
    COMBITRANS DISPOSABLE PRESSURE TRANSDUCER KIT
    MINIFLOW DISPOSABLE PRESSURE TRANSDUCER 63-600F
    DISPOSABLE DOME STOCK #D-300
    BARO-GRAF 24
    MX860, REUSABLE PRESSURE TRANSDUCER
    MODEL 700 PATIENT MONITOR
    SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS
    TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30
    DIGITAL SPHYGMOMANOMETER
    TATCH-IT
    MX900-DPT, DISPOSABLE PRESSURE TRANSDUCER

    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

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