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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: DTB FDA class 3

    Permanent Pacemaker Electrode

    Cardiovascular

    View full classification →

    The Permanent Pacemaker Electrode is an implantable cardiovascular device consisting of a conductive lead placed in direct contact with cardiac tissue to deliver electrical stimulation from a pacemaker generator and sense intrinsic cardiac activity over the long term. It is classified as an FDA Class 3 device, the highest risk category, and requires Premarket Approval (PMA) before marketing. The product code is DTB and it is regulated under 21 CFR 870.3680 within the Cardiovascular medical specialty. This device is flagged as an implant.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    BIOTRONIK ENDOCARDIAL PACING LEADS
    PERMANENT PACING LEAD, MODEL PY2
    PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU
    MODEL 5071 MYOCARDIAL PACING LEAD
    MODEL 4951M MYOCARDIAL UNIPOLAR LEAD
    ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP
    PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB
    MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS
    AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP
    AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP
    MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP
    PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB
    PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS
    OSCOR PERMANENT PACING LEAD RZ MODEL SERIES
    PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES
    ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668
    EX 45-BP, MODEL 330 132; EX 53-BP, MODEL 130 018; EX 60-BP, MODEL 330 133
    STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS
    PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051
    STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS
    YP 45/15-BP; YP 53/15-BP; YP 60/15-BP
    HT, MODEL HT PB
    SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854
    RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777
    SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , MODELS 120 444, 119 684, 120 438 AND 120 143
    RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL NUMBERS 124 396, 124 397, 124 395, 124 000
    TIR/TIJ AND POLYROX
    LOCATOR MODEL 4036
    ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606
    STELA MODEL UJ45 PACING LEADS
    STELA MODEL BJ44 AND BJ45 PACING LEADS
    OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR
    BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION
    MODEL 430-07 ENDOCARDIAL PACING LEAD
    INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD
    UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION & PASSIVE FIXATION
    MEDTRONIC MODEL 5058 BIPOLAR, IMPLANTABLE, SCREW-IN, VENTRICULAR/ATRIAL, TRANSVENOUS LEAD
    BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)
    MODEL 2188 CORONARY SINUS LEAD.
    TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS/TRANSVENOUS, PERMANENT SCREW-IN PACING LEADS
    MAXIM PF MODELS 033-581/033-590
    STERILIZATION
    CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD
    IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY
    INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD
    AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION)
    DF-1 TERMINAL CAP
    MODELS 5866-45 AND 5866-46 SIZING SLEEVE
    TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS
    PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING

    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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