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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: MWJ FDA class 2

    Electrocardiograph, Ambulatory (Without Analysis)

    Cardiovascular

    View full classification →

    An Ambulatory Electrocardiograph Without Analysis is a wearable device that continuously records the patient's electrocardiographic (ECG) signal over an extended period (typically 24-48 hours) for later offline review by a clinician, without onboard automated arrhythmia detection or interpretation. It is FDA Class 2, requiring 510(k) clearance, with product code MWJ under 21 CFR 870.2800 in the Cardiovascular specialty. The device is not an implant and is not life-sustaining.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    ZywieZ3 Sensor & Adhesive
    HeartBeam AIMIGo(TM) System
    ASSURE Wearable ECG
    Eclipse MINI Model 98900
    Biotres
    Q Patch
    Biotres
    Eclipse PRO
    Integrated CardioRespiratory System
    NR Recorder
    H3+ Holter Recorder
    DR300 HOLTER MONITOR
    DMS 300-2W HOLTER ECG RECORDER
    BRAEMAR CARDIOKEY HOLTER RECORDER
    SEER 1000
    CARDIOMEM
    EZSLEEP SLEEP QUALITY RECORDER
    INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER
    MH1 MICROHOLTER RECORDER
    KENZ CARDY302 MAX
    MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS
    BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS
    ACTIWAVE 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, ACTIWAVE CARDIO MODEL 08-514, 08-521, 08-536, 08-557, 08-603
    CHROMA, MODEL: RZ153C
    WALK400H
    AUDICOR, HEMO AMBULATORY MONITOR
    E3-80 PORTABLE ECG RECORDER & ANALYZER
    DL900 SERIES HOLTER RECORDER
    CARDIOMEM CM 3000-12BT
    AUTO DETECT FOR TELAHEART DR200/E-A
    MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER
    DMS 300-2, 300-3 AND 300-4
    TELAHEART DIGITAL RECORDER
    CARDIOMEM CM 3000-12
    SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM
    HOLTER RECORDER H3+
    BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER
    SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER
    RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONITOR, MODEL 100
    DIGITAL AMBULATORY ECG (HOLTER) RECORDER
    CLICK HOLTER
    SPIDERVIEW
    ER800 SERIES ECG EVENT RECORDER
    SEER LIGHT COMPACT DIGITAL HOLTER RECORDER
    H12+HOLTER RECORDER
    LIFECARD CF 7 DAY
    CARDIONET AMBULATORY ECG MONITOR, MODEL CN1000A
    NEXAN SYSTEM, MODEL NX-300
    CARDIOVISE ECG INTERPRETATIVE SOFTWARE
    ARIA

    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

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