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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: DXO FDA class 2

    Transducer, Pressure, Catheter Tip

    Cardiovascular

    View full classification →

    The Catheter Tip Pressure Transducer is a cardiovascular device that incorporates a miniature pressure sensor at the tip of a catheter to measure intravascular or intracardiac pressures directly within the body. It is classified as FDA Class 2, indicating moderate risk, and must obtain 510(k) clearance before marketing. The product code is DXO and the applicable regulation is 21 CFR 870.2870, under the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    OptoMonitor 3
    ACIST RXi System (016616); ACIST Navvus II Catheter (016675_
    TruWave Disposable Pressure Transducer
    OptoMonitor 3
    OptoMonitor 3
    Comet II Pressure Guidewire
    OptoMonitor
    Zurich Pressure Guidewire System Model 100
    TruWave Disposable Pressure Transducer
    PressureWire X
    TruWave Disposable Pressure Transducer
    Mikro-Cath Pressure Catheter
    OptoMonitor II
    PressureWire X Guidewire
    Comet Pressure Guidewire
    TruWave Disposable Pressure Transducer
    PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 300
    TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
    CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER
    PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300
    PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER
    CARDIA-CATH
    MIKRO-CATH, MODEL 825-0101
    PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER
    SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX
    PRESSUREWIRE CERTUS, MODELS 12006 AND 12306
    WIRELESS PHYSIOLOGIC MONITORING SYSTEM
    PRESSURE WIRE SENSOR, MODELS 12004/12304
    PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304
    FLOW DIRECTED MIKRO-TIP PRESSURE TRANSDUCER
    INNERSENSE DISPOSABLE MICROTRANSDUCER
    PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600
    INNERSENSE(TM) DISPOSABLE MICROTRANSDUCER
    TRANSDUCER, PRESSURE, CATHETER TIP
    MODIFICATIONS TO SERIES OF CARDIAC CATHETERS
    MILLAR NONMAGNECTIC MIKRO-TIP CATHETER PRESS. TRAN
    SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER
    MILLAR MIKRO-TIP PULSE TRANSDUCER
    DISPOSABLE CATHETER PRESSURE TRANSDUCER
    PRECEPT-GT(TM) MICROSENSOR PRESSURE MONITOR CATH.
    PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER
    PRECEPT-PT(TM) MICROSENSOR PRESSURE MONITOR CATH.
    ULTRASONIC IMAGING CATHETER
    PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER
    SENTORR ARTERIAL PRESSURE SENSOR
    VITALERT 2000 VITAL SIGNS MONITOR
    DISPOSABLE CATHETER PRESSURE TRANSDUCER
    ESCORT PORTABLE PATIENT MONITOR
    CAMINO COMPARTMENTAL PRESS MONITOR CATH/110-4D
    FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00

    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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