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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: DRX FDA class 2

    Electrode, Electrocardiograph

    Cardiovascular

    View full classification →

    The Electrocardiograph Electrode is a cardiovascular sensor device placed on the body surface to detect electrical potentials generated by the heart, providing the signal input for electrocardiographic recording and analysis. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DRX and it is regulated under 21 CFR 870.2360 within the Cardiovascular medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Physiotrace
    HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE
    BIOMODULE 3-M1
    CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES
    IP-SET
    AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X
    INTCO TAB ELECTRODE
    12 LEAD GLOVE
    NEONATAL ECG ELECTRODE, M203KEN
    DISPOSAL ECG ELECTRODES, MODEL EASYRODE
    QWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCH
    SKINTACT AND VARIOUS OTHER TRADENAMES
    CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES
    TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE
    PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1
    TELECTRODE WET GEL ECG ELECTRODE
    AUDICOR SENSOR, MODELS: 2.0, 3.0
    SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE
    SKINTACT AND VARIOUS OTHER TRADENAMES
    TEXTRONICS ECG ELECTRODE
    CARDIOBELT ELECTRODE BELT
    ORI F6T DRY ECG MONITORING ELECTRODE
    AMBU WHITE SENSOR CFM, CFL
    AMBU BLUE SENSOR NEO AND NEO X
    MACTRODE 3
    PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20
    ACCU-LEAD
    ELECTRODE
    ACCUHEART ELECTRODE BELT
    12-LEAD GLOVE
    AMBU DISPOSABLE ECG ELECTRODE
    DISPOSABLE MONITORING ELECTRODES
    AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S
    PROTAB ECG TABB ELECTRODE
    SKINTACT ECG ELECTRODE
    AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR)
    BODY SIGNAL ECG ELECTRODE
    VERMED A10021 RESTING EKG TAB ELECTRODE
    SKINTACT ECG TAB ELECTRODE
    SKINTACT
    SKINTACT
    SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL
    NIKOMED TRACE 1 ECG ELECTRODES
    SKINTACT ECG ELECTRODE
    ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE
    BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA
    NEOLEAD
    SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801
    CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002
    V QUICK PATCH

    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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