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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: FDT FDA class 2

    Duodenoscope And Accessories, Flexible/Rigid

    Gastroenterology, Urology

    View full classification →

    The Duodenoscope and Accessories (Flexible/Rigid) (product code FDT) is an endoscopic instrument used to examine the duodenum and perform various procedures within the duodenum, including endoscopic retrograde cholangiopancreatography (ERCP). It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.1500 in the Gastroenterology and Urology specialty. If the device is reusable, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807).

    510(k) Clearances

    35 matches
    K Number
    Device Name
    FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000
    Single Use Distal Cover MAJ-2315 (MAJ-2315)
    EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)
    Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)
    PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )
    Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2
    Evis Exera III Duodenovideoscope Olympus TJF-Q190V
    PENTAX Medical Video Duedenoscope ED34-i10T2
    Pentax Medical Video Duodenoscope ED32-i10
    Evis Exera III Duodenovideoscope Olympus TJF-Q190V
    FUJIFILM Distal End Cap
    Ambu Duodeno System
    Evis Exera III Duodenovideoscope Olympus TJF-Q190V
    EXALT Model D Single-Use Duodenoscope, EXALT Controller
    Pentax Medical Video Duodenoscope ED34-i10T2
    PENTAX Medical ED-3490TK Video Duodenoscope
    FUJIFILM Duodenoscope Model ED-580XT
    FUJIFILM Duodenoscope Model
    FUJIFILM Duodenoscope Model
    PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope
    PENTAX MEDICAL ED-3490TK, Video Duodenoscope
    PENTAX Medical ED34-i10T, Video Duodenoscope
    Fujifilm Duodenoscope Model ED-530XT
    EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V
    CRE BALLOON DILATATION CATHETER
    PENTAX ED-3490TK, VIDEO DUODENOSCOPE
    XTJF TYPE Q160VF1
    FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5
    XTJF-160AF DUODENOVIDEOSCOPE
    OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS MAJ-311/MAJ-411 DISTAL COVERS
    KARL STORZ FRIMBERGER VARIOGUIDE
    ED-3410, VIDEO DUODENOSCOPE
    ED-344OT
    OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES
    PENTAX FD-34A DUODENOFIBERSCOPE

    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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