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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: HGL FDA class 2

    Transducer, Ultrasonic, Obstetric

    Obstetrics/Gynecology

    View full classification →

    The Obstetric Ultrasonic Transducer is a device that converts electrical energy into ultrasonic waves and receives reflected echoes for diagnostic imaging of the uterus, fetus, and pelvic structures during obstetric examinations. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HGL, regulated under 21 CFR 884.2960, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.

    510(k) Clearances

    36 matches
    K Number
    Device Name
    ULTRASOUND TRANSDUCER, MODEL US917
    ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION
    OP3/VP4
    ULTRASONIC PULSED DOPPLER IMAGING SYSTEM
    EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE
    ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER
    MER MULTIPLANE VAGINAL PROBE (MVP)
    TRANSVAGINAL TRANSDUCER ASSEMBLY
    ALOKA MODEL SSD-650 ULTRASOUND IMAGING SYSTEM
    MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLER
    5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER
    5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER
    HP MODEL M1318A TRANSVAGINAL ULTRASOUND TRANSDUCER
    DYMAX ENDOVAGINAL BIOPSY GUIDE
    GENERAL IVT NEEDLE GUIDE KIT, STERILE
    SIEMENS INTRAVAGINAL TRANSDUCER
    KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM
    KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM
    ULTRASOUND BREAST SCANNER W/CHANGES IN TRANS/RECE.
    ANNULAR ARRAY SCANHEAD
    ACUSON TV519 TRANSDUCER
    280SL IMAGING SYSTEM TRANVAGINAL PROBES
    TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE
    7.5 MHZ ENDOVAGINAL PROBE
    DIASONICS TRANSVAGINAL, TV 7.5 MHZ PROBE
    BIOPSY NEEDLE GUIDE ATTACHMENT
    TRANSVAGINAL PROBE, MODEL ED65M-TV
    FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01
    ACUSON S228, S519 & L558 TRANSDUCERS
    ACUSON S328, L382, L538 & L312 TRANSDUCERS
    TRANSVAGINAL TRANSDUCER, 5MHZ
    1MHZ CW DOPPLER TRANSDUCER W/LILY ANTEPARTUM #507
    3.0 MHZ LINEAR ARRAY PROBE MODEL UST 5031
    BIO-DERM COUPLING LOTION
    DIAG. ULTRASOUND B-SCANNER
    ARTIUS 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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