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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: DXY FDA class 3

    Implantable Pacemaker Pulse-Generator

    Cardiovascular

    View full classification →

    The Implantable Pacemaker Pulse Generator is a cardiovascular device surgically implanted in the body to deliver controlled electrical impulses to stimulate the heart when its natural rhythm is inadequate or absent. It is classified as FDA Class 3, the highest risk category, which requires approval through a Premarket Approval (PMA) application demonstrating safety and effectiveness. The product code is DXY and the applicable regulation is 21 CFR 870.3610, under the Cardiovascular medical specialty. This device is an implant.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A
    OPUS S MODEL 4121 AND 4124 PACEMAKERS
    PIKOS LP 01, PIKOS LP E01
    ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)
    MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)
    NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01
    MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS
    OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)
    PELLETHANE 75D
    CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER
    TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES
    CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER
    PIKOS E 01-B
    MINIX/MINIX ST PULSE GENERATORS
    PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER
    CCS MAESTRO II SERIES 200 CARDIAC PACEMAKER
    MEDTRONIC MINIX & MINIX ST PULSE GENERATORS
    ASTRA T2, ASTRA T4, ASTRA T6
    INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG
    SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER
    PIKOS 01 & PIKOS E 01
    MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER
    MODEL 4220
    MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE
    8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS
    MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE
    TRIOS 02
    OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE
    MEDTRONIC MODEL 5301B TEST CABLE
    MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE
    VACUUM BAKE CYCLE
    IMPLANTABLE PULSE DEVICES
    NEOS (TM) 02 B PULSE GENERATOR
    MODIFIED MEDTRONIC CLASSIX MODEL 8438 PULSE GENE.
    MINIX, MINIX ST, NEW IC: L74
    MODIFIED MODEL 5401B TEST CABLE
    OPTIMA MPT MODEL 5281E AND MODEL 5282E
    OPUS MODEL 4021, VVI, 5MM UNIPOLAR
    MEDTRONIC SPECTRAX SXT MODEL 8423M PULSE GENERATOR
    KALOS 05 PULSE GENERATOR
    NANOS
    NEOS 02
    LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD
    OPUS MODEL 4001
    ADD'L LABELING TO MINIX MODELS AND MINIX ST MODELS
    OPUS MODELS 4033 AND 4034
    OPTIMA MPT AND SPT PACEMAKERS
    HOME BLOOD PRESSURE KIT, ANEROID
    MINIX 8341M AND MINIX ST 8331M PULSE GENERATORS
    OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR

    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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