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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: DXG FDA class 2

    Computer, Diagnostic, Pre-Programmed, Single-Function

    Cardiovascular

    View full classification →

    The Pre-Programmed Single-Function Diagnostic Computer is a cardiovascular computing device designed to perform a specific diagnostic calculation or analysis function, such as computing cardiac output or vascular resistance, based on pre-set algorithms applied to physiological input signals. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DXG and it is regulated under 21 CFR 870.1435 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Cogent™ Hemodynamic Monitoring System; Cogent™ HMS
    Hypotension Decision Assist Model HDA-OR2
    PulsioFlex Monitoring System with ProAQT Sensor
    EV1000 Clinical Platform
    Hypotension Decision Assist
    Argos
    PulsioFlex Monitoring System
    LiDCOunity v2 Hemodynamic Monitor
    LiDCOunity Monitor
    TRANSONIC ELSA SYSTEM
    TRANSONIC HCM 103 SYSTEM
    TRANSONIC HCM 102 SYSTEM
    TEBCO-W
    EV1000 CLINICAL PLATFORM
    VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR
    E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES
    CARDIOX FLOW DETECTION SYSTEM
    LIDCO CNAP MODULE
    LIDCORAPID V2 MONITOR
    TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM
    PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE
    PULSIOFLEX
    EV1000 CLINICAL PLATFORM
    VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR; VIGILEO APCO / OXIMETRY MONITOR
    EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M
    CHEETAH NICOM SYSTEM
    PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48)
    NAVIGATOR CLINICAL GUIDENCE SYSTEM
    MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
    TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM
    CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM
    NICOM ELECTRODES
    INFINITY PICCO POD, MODEL MS16734
    PULSION PICCO-2, MODEL 8500
    VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
    PULSION PICCO PLUS, MODEL 8100
    EW200 SYSTEM (OXYGEN SATURATION MONITORING SYSTEM) AND PRESEP OXIMETRY CATHETER
    VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG2
    NICOM
    VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/CONTINUOUS END DIASTOLIC VOLUME (CC0/SVO2/CEDV) MONITOR
    MODIFICATION TO: HORIZON 9000WS
    LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 70
    ABBOTT Q2 PLUS S02/CONTINUOUS CARDIAC OUTPUT COMPUTER, LIST NUMBER 56711
    PULSECO HEMODYNAMIC MONITOR CM71
    VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS
    PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM
    MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS
    LIDCO SYSTEM
    ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3/T)
    OXIMETRIX 4 COMPUTER 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.

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