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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: ITX FDA class 2

    Transducer, Ultrasonic, Diagnostic

    Radiology

    View full classification →

    A diagnostic ultrasonic transducer is a device that converts electrical energy into ultrasonic waves and receives returning echoes to generate diagnostic images of internal body structures, used with ultrasound imaging systems across a wide range of clinical applications. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is ITX, regulated under 21 CFR 892.1570, within the Radiology medical specialty. This device is eligible for third party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)
    Mendaera Guidance System
    Accuro® 3S Needle Guide Kit
    Ultrasound Transducer Cover
    UltraDrape UGPIV Barrier and Securement (34-15)
    Transducer Probe Cover
    TP Pivot Pro™ Needle Guide
    Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)
    VitroPRO
    Disposable Needle Guides and Grids
    Intraoperative Ultrasound Probe Cover
    Transducer Probe Cover
    VitroPRO
    Natural Rubber Latex Ultrasound Transducer Probe Covers
    CIV-Clear cover
    EMM Ultrasonic Transducer Cover
    Disposable Intraoperative Probe (DIOP8)
    Vscan Air
    EZ-Cover
    Opticross 35 15 MHz Peripheral Imaging Catheter
    Envision ultrasound pad and cover
    Cook-Swartz Doppler Flow Probe
    Disposable guides KDNG00
    Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range
    ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor
    GTK Disposable Needle Guides
    Pinpoint GT Needle Guide Kits
    A-View
    iSR'obot Biopsy Kit
    UST-5550-R; UST-5536-R; L43K
    Verza Guidance System
    Precision Point Biopsy Needle Guide
    Sheathes Ultrasound Probe Covers
    Permanent Sled Bag
    Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System, ARIETTA 70 Diagnostic Ultrasound System
    REUSABLE GUIDE
    INTRA-OPERATIVE ULTRASOUND TRANSDUCER
    6VT-D ULTRASOUND TRANSDUCER
    EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION,
    NON-PYROGENIC ULTRASOUND TRANSDUCER COVER
    MDU5 PLUS STERILE BAG
    C1-6-D ULTRASOUND TRANSDUCER
    C2-9-D ULTRASOUND TRANSDUCER
    VIVID I DIAGNOSTIC ULTRASOUND SYSTEM, VIVID Q DIAGNOSTIC ULTRASOUND SYSTEM
    V5MS TRANSDUCER
    SONICEYE ULTRASOUND TRANSDUCER
    EUCLID (TM) TIER 1-GW ACCESS SYSTEM
    PUREIMAGE ULTRASOUND TRANSMISSION GEL
    HIGHLAND INSTRUMENTS CES AND TUS INSTRUMENT HOLDER
    KONIX ULTRASOUND GEL

    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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