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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: DTE FDA class 2

    Pulse-Generator, Pacemaker, External

    Cardiovascular

    View full classification →

    The External Pacemaker Pulse Generator is a cardiovascular device used outside the body to deliver temporary pacing impulses to the heart through electrode leads, typically during emergency situations, perioperative care, or while awaiting implantation of a permanent pacemaker. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DTE and it is regulated under 21 CFR 870.3600 within the Cardiovascular medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Solo Pace Control
    Lifetech Cardio Temporary Pacemaker
    Medtronic Model 5392 External Pulse Generator (EPG)
    Medtronic Model 5392 External Pulse Generator (EPG)
    Lifetech Cardio Model 8301 Temporary Pacemaker
    Medtronic Model 5392 External Pulse Generator (EPG)
    Medtronic Model 53401 External Pulse Generator (EPG)
    Medtronic Temporary External Pacemaker 53401
    Medtronic Model 5392 External Pulse Generator (EPG)
    Medtronic Model 5392 External Pulse Generator (EPG)
    MEDTRONIC EXTERNAL PULSE GENERATOR (EPG)
    PSA SERIES
    ERA 3000 PACING SYSTEM ANALYZER
    PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR
    GALIX PACESTAR
    OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIES
    OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE
    ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825
    PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V
    TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528
    MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM
    MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL
    ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER
    PACE 101H
    ZOLL STATPADZ RADIOLUCENT ADULT MULTI-FUCTION ELECTRODES MODEL 8900-4004
    REMINGTON MEDICAL DISPOSABLE EXTENSION CABLE FAS-LOC FL-601
    POWERCHARGER
    MODEL 4800 ACCUPACE PACING SYSTEM ANALYER
    EXTERNAL DEMAND PACEMAKER
    CPI MODEL 2215
    CHRONOCOR VI MODEL 5012
    MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER
    CPI MODEL 2215 & SEAMED MODEL 3400
    MODIFIED MODEL 5330 AV DEMAND PULSE GENERATOR
    MODELS 4201, 4231 & 4235 EXTENSION CABLES
    TRANS-PACE 100
    MODEL EC4542G MINIATURE
    MODEL 5330 EXTERNAL A-V SEQUENTIAL DEMAND PULSE
    SEAMED MODEL 3300 DUAL CHAMBER PACING SYSTEM ANALY
    SEAMED MODEL 3200
    MINIATURE TEMP. CARDIAC PACEMAKERS EC4542 & EC4543
    ERA-20
    MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKER
    SEA MED MODEL 6000
    SEAMED MODEL 4000
    CHRONOCOR V EXTERNAL PACER, MODEL 297A
    SEAMED 4000
    SEAMED MODEL 6000
    EXTERNAL PULSE GENERATOR FOR TEMP. STIM
    RAPID ATRIAL PACER

    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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