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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: KNG FDA class 2

    Monitor, Ultrasonic, Fetal

    Obstetrics/Gynecology

    View full classification →

    An Ultrasonic Fetal Monitor is a diagnostic device used in obstetrics to continuously detect and record fetal heart rate using Doppler ultrasound technology, providing real-time assessment of fetal wellbeing during pregnancy and labor. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket clearance. The product code is KNG and the applicable regulation is 21 CFR 884.2660 in the Obstetrics and Gynecology specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Doppler FHR Detector (BF-500D+, BF-560)
    Ultrasonic Fetal Doppler
    Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)
    Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)
    Fetal Doppler
    Fetal Doppler
    HeraBEAT™ US
    Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D)
    Fetal Doppler, Model FD88
    Fetal Doppler
    Ultrasonic Doppler (Model YM-2T8)
    SD1 Ultrasonic Pocket Doppler
    SD5 & SD6 Ultrasonic Tabletop Doppler
    ULTRASONIC POCKET DOPPLER
    FETAL ULTRASONIC MONITOR AND ACCESSORIES
    TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER
    FETAL DOPPLER
    PD-100 SERIES ULTRASONIC POCKET DOPPLER
    F10
    FETAL DOPPLER JPD-100S
    DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200
    DOPPLER FETAL HEARTBEAT RATE DETECTOR
    ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6
    CONTEC POCKET FETAL DOPPLER
    MODEL PC-860 FETAL DOPPLER
    SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR
    BABYBEAT CORDLESS
    SONOTRAX ULTRASONIC POCKET DOPPLER
    OB1 OBSTETRICAL DOPPLER
    HANDYDOP
    ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX
    LIFEDOP DOPPLER
    ECHO SOUNDER, ES-102EX
    BABYCOM
    CADENCE DOPPLER ULTRASOUND SYSTEM
    MULTI DOPPLEX II / FETAL DOPPLEX II
    POCKET SIZE FETAL HEART DETECTOR
    OBTRASOUND STETHOSCOPE FETAL CALC
    UST-974-5 CONVEX TRANSDUCER
    IMEX DOP-TONE II
    HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D140
    TOITU DOPPLER FETUS DETECTOR, FD-400D
    PIE MEDICAL SCANNER 1000
    ULTRASOUND LINEAR/SECTOR SCANNER 1100
    HUNTLEIGH DOPCORD, D140
    COMBISCOPE
    OBSTETRICAL DOPPLER
    PROGRAMALITH PROGRAMMER
    FETAL PULSE DETECTORS, F50/F60
    DOPPLEX-PLB & PXB

    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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