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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: EOB FDA class 2

    Nasopharyngoscope (Flexible Or Rigid)

    Ear, Nose, Throat

    View full classification →

    The nasopharyngoscope is a flexible or rigid endoscopic instrument used to directly visualize the nasopharynx and assess conditions such as polyps, tumors, or adenoid enlargement in the Ear, Nose, and Throat specialty. It is classified as FDA Class 2, requiring 510(k) premarket clearance to demonstrate substantial equivalence to an existing legally marketed device. The product code is EOB, regulated under 21 CFR 874.4760 in the Ear, Nose, Throat specialty. This device is eligible for third-party review. If the device is reusable, validated reprocessing instructions and reprocessing validation data must be included in the 510(k) submission.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Portare System (FA-001)
    VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)
    MonoStereo
    Rhinolaryngoscope system
    ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)
    PatCom Distal Chip Endoscope
    Single-use Flexible Rhinolaryngoscope; Digital Video Monitor
    RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP
    Single-Use Flexible Rhinolaryngoscope
    PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10
    Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3
    ENT Nasopharyngoscope and Accessories
    Zsquare ENT-Flex Endoscope
    Peregrine Endoscopy System
    ENTity WiFi Video Nasopharyngoscope System
    HD Video Rhino Laryngoscope
    Colibri Endoscopy System
    CMOS Video Rhino-Laryngoscope SSU
    Rhino-Laryngo Videoscope Olympus ENF-VT3
    Precision S 4K Sinuscope
    Ambu aScope 4 RhinoLaryngo Intervention
    PENTAX Medical ENT Video Imaging System
    Ambu aScope 4 RhinoLaryngo Slim
    CMOS Video-Rhino-Laryngoscope System
    RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4
    PENTAX Medical EPK-3000 Video Imaging System
    Ambu aScope RLS Slim
    Rhino-Laryngo Fiberscope Olympus ENF-GP2
    PENTAX Medical VIVIDEO ENT Videoscope Solution
    Sharpsite AC Rigid Endsocope
    PENTAX Medical EPK-3000 Video Imaging System
    KARL STORZ Slim Nasopharyngolaryngoscope
    Medrobotics Flex Robotic System
    ShenDa Sinuscope
    AED Sinuscope
    PENTAX Medical ENT Video Imaging System
    TIPCAM 1S 3D System
    3NT endoscopy system
    ULYSS Multi View Sinuscope
    ULTRA Telescopes
    InstaClear Lens Cleaner
    Medrobotics Flex System
    CMOS Video Nasopharyngoscope System
    SCHOELLY SINUSCOPE
    ECLERIS SINUSCOPE
    ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
    CMOS VIDEO NASOPHARYNGOSCOPE SYSTEM
    CMOS VIDEO RHINO-LARYNGOSCOPE SYSTEM MODEL 11101CM
    ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
    VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR

    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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