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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: LRC FDA class 1

    Instrument, Ent Manual Surgical

    Ear, Nose, Throat

    View full classification →

    ENT manual surgical instruments are hand-held tools used by otolaryngologists during surgical procedures involving the ear, nose, and throat, including instruments for dissection, grasping, cutting, or manipulating tissue in these anatomical regions. They are classified as a Class 1 (lowest risk) device, subject only to general controls, representing the least burdensome regulatory category. The product code is LRC, regulated under 21 CFR 874.4420, within the Ear, Nose, and Throat medical specialty. No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    BB 8 Sinus Dilation Kit
    VenSure LightGuide
    SINUSPRIME Dilation System
    Next Generation Balloon Dilation System
    VenSure Balloon Device, VenSure Nav Balloon Device
    Dillard Nasal Balloon Catheter
    RELIEVA ULTIRRA Sinus Balloon Catheter
    Sinusway Dilation System
    MESIRE - Balloon Sinus Dilatation System
    Relieva SpinPlus Nav Balloon Sinuplasty System
    Relieva UltirraNav Sinus Balloon Catheter
    Vent-Os Sinus Dilation family
    Relieva Scout Multi-Sinus Dilation System
    NuVent EM Sinus Dilation System
    XprESS Multi-Sinus Dilation System
    PassAssist LED Light Fiber
    DSS Sinusplasty Balloon Catheter
    Relieva SpinPlus Balloon Sinuplasty System
    ACCLARENT SE Inflation Device
    XprESS Multi-Sinus Dilation Tool
    PATHASSIST LED LIGHT FIBER
    RELIEVA SCOUT SINUS DILATION SYSTEM
    PATHASSIST LIGHT SEEKER
    BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS
    VENT-OS SINUS DILATION SYSTEM
    EM SINUS DILATION SYSTEM
    SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT
    XPRESS MULTI-SINUS DILATION TOOL
    PATHASSIST LED LIGHT FIBER
    RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM
    SINUS DILATION SYSTEM
    XPRESS MULTI-SINUS DILATION TOOL
    XPRESS MULTI-SINUS DILATION TOOL
    PATHASSIST LIGHT FIBER
    PATHASSIT LIGHT SEEKER
    PATHASSIST LIGHT SEEKER
    XPRESS MULTI-SINUS DILATION TOOL
    RELIEVA SPIN SINUS DILATION SYSTEM
    PATHASSIST LIGHT FIBER
    RELIEVA SOLO ELITE SINUS BALLOON CATHETER
    ENTELLUS MEDICAL SINUS GUIDEWIRE
    ILLUMINATING SINUS SEEKER
    XPRESS BALLOON DEVICE
    ENTELLUS MEDICAL BALLOON DEVICE
    FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT)
    MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM
    ENTELLUS MEDICAL RS-SERIES SYSTEM
    RELIEVA SINUS BALLOON CATHETER
    RELIEVA SINUS BALLOON INFLATION DEVICE
    RELIEVA SINUS BALLOON DILATION CATHETER

    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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