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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: NLH FDA class 2

    Catheter, Recording, Electrode, Reprocessed

    Cardiovascular

    View full classification →

    The Reprocessed Recording Electrode Catheter is a reprocessed cardiovascular electrophysiology device used to record intracardiac electrical signals during diagnostic electrophysiology studies; reprocessing validation data must be included in a 510(k) submission. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NLH and regulation 21 CFR 870.1220 in the Cardiovascular specialty. The device is not an implant and is not life-sustaining.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter
    Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter
    Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT)
    Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter
    Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (401150, 401206, 401207, 401210, 401211, 401212, 401222, 401223, 401226, 401227, 401228, 401260, 401261, 401271, 401305, 401306, 401309, 401310, 401311, 401312, 401317, 401353, 401357, 401381, 401392, 401399, 401400, 401425, 401430, 401433, 401434, 401435, 401436, 401438, 401441, 401442, 401443, 401444, 401445, 401448, 401449, 401450, 401451, 401453, 401466, 401468, 401
    Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)
    Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter
    Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter
    Reprocesses Umbilical Cable
    Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters
    Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID)
    Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled
    Reprocessed Achieve Catheter Connecting Cable
    Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter
    Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter
    Reprocessed Response Diagnostic Electrophysiology Catheter
    Reprocessed CS Diagnostic Electrophysiology Catheter
    Reprocessed Marinr Diagnostic EP Catheter
    Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter
    Reprocessed Torqr Diagnostic EP Catheter
    Reprocessed DecaNav Diagnostic Electrophysiology Catheter
    Reprocessed Halo XP Diagnostic Electrophysiology Catheter
    Reprocessed CristaCath Diagnostic Electrophysiology Catheter
    Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID)
    Supreme and Response Electrophysiology Catheters
    Reprocessed Viking Diagnostic Electrophysiology Catheters
    Reprocessed Response Diagnostic Electrophysiology Catheters
    Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter
    Reprocessed Orbiter ST Steerable Diagnostic EP Catheter
    Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters
    Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter
    Reprocessed Inquiry Steerable Diagnostic EP Catheter
    Reprocessed Livewire Steerable Diagnostic EP Catheter
    Reprocessed Polaris X Steerable Diagnostic EP Catheter
    Reprocessed Electrophysiology Catheter
    Livewire Electrophysiology Catheter
    Reprocessed Electrophysiology Diagnostic Catheters
    REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
    REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER
    REPROCESSED ELECTROPHYSIOLOGY CATHETERS
    REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
    REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER
    REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
    REPROCESSED ELECTROPHYSIOLOGY CATHETERS
    REPROCESSED ELECTROPHYSIOLOGY CATHETERS
    REPROCESSED ELECTROPHYSIOLOGY CATHETERS
    REPROCESSED ELECTROPHYSIOLOGY CATHETERS
    REPROCESSED ELECTROPHYSIOLOGY CATHETER
    REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS
    REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS

    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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