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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: DXK FDA class 2

    Echocardiograph

    Cardiovascular

    View full classification →

    The Echocardiograph is a cardiovascular imaging device that uses ultrasound waves to produce real-time images of the heart's structures and blood flow, enabling non-invasive assessment of cardiac anatomy, wall motion, valvular function, and hemodynamics. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DXK and it is regulated under 21 CFR 870.2330 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter
    Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)
    IN-VISION IMAGING SYSTEM
    9750 ATHENA ETHERNET OPTION
    ACCESSORY TO GENESIS III (GCFM)
    CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600
    MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST
    CINE/VIEW PLUS - CARDIOLOGY WORKSTATION
    SOFTWARE PROGRAM USED W/PRISM PRODUCTS
    VISTA VIEWING STATION
    CINE'VIEW - STRESS ECHO & IMAGE REVIEW
    PATIENT CARE MANAGEMENT SYSTEM MODIFICATION
    INTERSPEC APOGEE
    WASHINGTON CARDIAC MONITOR
    MODEL MD-5 DOPPLER
    TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN
    ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND
    ADD'L TRANSDUCER FOR USE W/EUB-565 ULTRASOUND
    LEOCOR CORFLO(TM) PUMP
    CVIS INSIGHT IMAGING CATHETER
    DOPPLER OPTION FOR PLATINUM
    EUB-165
    ULTRAMARK 7 ULTRASOUND SYSTEM
    GENESIS III, (MOD. 7003/7004)
    MODEL SSH-140A ULTRASOUND IMAGING SYSTEM
    SONOMICROMETER, ULTRASONIC DIMENSION SYSTEM, CARD.
    RESUBMITTED AI 5200 ULTRASOUND TRANSDUCER
    CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST.
    SSD-870 CARDIO VASCULAR PHASED ARRAY SECTOR SCANN.
    EUB-305 DIAGNOSTIC ULTRASOUND DEVICE
    RT5000 W/QUANTI. SPEC. DOPPLER, CW DOPP. MODIFICA.
    GENESIS II, 2.5/5.0 MHZ S.E/5.0MHZ/3.5 16/19 MM AN
    SONOLINE CF
    SERIES 77000 ULTRASOUND IMAGING SYSTEM
    GENESIS II
    MULTIPLE
    SSD-650 LINEAR, CONVEX SECTOR, ULTRASOUND SCANNING
    MODEL 600 VASCULAR DUPLEX IMAGER
    EUB 151 ULTRASOUND SYSTEM/EUB 150 ULTRASOUND
    ATL'S ULTRAMARK 6 ULTRASOUND SYSTEM
    KENZ-ECG 102
    MODEL UST-SSD 880L1-5 TRANESOPHAGEAL PHASED ARRAY
    CFM-10 VINGMED COLOR FLOW MAPPING SYSTEM
    SONOLAYER S, SSH-60A/SDS-60A
    SONOLINE SX ULTRASOUND SCANNER
    SONOLAYER S, SSH-65A
    IRREGULAR CURVE TRACING REVISITION & DOPPLER
    750 SD ULTRASOUND SCANNER(MODIFICATION)
    KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM
    ACCUCOM CARDIAC OUTPUT MONITOR

    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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