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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: DTD FDA class 2

    Pacemaker Lead Adaptor

    Cardiovascular

    View full classification →

    The Pacemaker Lead Adaptor is an implantable cardiovascular accessory used to connect pacemaker leads of differing connector types or sizes to a pacemaker generator, enabling compatibility between components from different systems or generations. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DTD and it is regulated under 21 CFR 870.3620 within the Cardiovascular medical specialty. This device is flagged as an implant.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    IS4/DF4 Port Plug
    6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP
    CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020
    PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV
    PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR
    PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS
    A1-CS-SB Y-ADAPTER, MODEL 124 871
    MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT
    MODEL 2872 BIPOLAR LEAD ADAPTOR KIT
    A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE
    BK-N SEALING CAP
    BK-A; BK-B; BK-IS SEALING CAP
    IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069
    BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM
    MISCELLANEOUS PACING LEAD
    ADAPTING SLEEVE KIT MODEL 4023
    MODEL 6984M LEAD EXTENDER KIT
    UNIPOLAR UPSIZING ADAPTOR
    LEAD TERMINAL PIN CAPS, VARIOUS MODELS
    MODELS 5866-24M/5866-38M/5866-40M/6986M ADAPT KIT
    MODEL 5866-9M & MODEL 6981M
    MODEL 6985M TEMPORARY UNIPOLAR LEAD EXTENDER KIT
    MODEL 5857-3M LEAD END CAP KIT
    BIFURCATED VS-1 TO VS-1 LEAD ADAPTOR
    MODEL 5866-37M LEAD ADAPTOR KIT
    A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH PACE.
    SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS
    MODEL 5866-34 LEAD ADAPTOR KIT
    UPSIZING LEAD ADAPTERS 5.0MM PEEL-AWAY ADAPTER
    IMPLANTABLE ADAPTOR 033-380
    3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100
    TELECTRONICS PACING SYSTEMS VS-1 TO 6MM UPSIZING
    ALTERNATE PACKAGING CONF. OF PACEMAKER LEAD ADAP.
    ADAPTAID(TM) ADAPTER SLEEVE MODEL 366-33
    DAIG PACEMAKER LEAD ADAPTOR
    PACEMAKER LEAD ADAPTER
    MODEL 366-08 ADAPTAID CONNECTOR ADAPTER
    IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLY
    BIOPORE 493-05 ENDOCARDIAL IMPLANTABLE PACING LEAD
    MEDTRONIC MODEL 4016 BIPOLAR ENDOCARDIAL SCREW-IN
    CCS MODEL AV-106 IMPLANTABLE A-V DATA LEAD
    MEDTRONIC MODEL 5561
    329 CORDIS ENCOR PREVENOUS ARTRIAL & VENTRICULAR
    MODEL 493-04 POLYFLEX R IMPLANTABLE PACING LEAD
    MODEL 483-06 POLYFLEX IMPLANTABLE PACING LEAD
    MEDTRONIC 5064
    PACESETTER SYSTEMS, MODEL 458 ADAPTER SLEEVE
    PACESETTER SYSTEMS INC. ENDOCARDIAL FINNED LEAD
    PACESETTER SYSTEMS, ENDOCARDIAL FIRM LEAD
    MEDTRONIC 5061 ENDOCARDIAL PACING LEAD

    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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