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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: CCW FDA class 1

    Laryngoscope, Rigid

    Anesthesiology

    View full classification →

    The Rigid Laryngoscope is an anesthesiology device with a non-flexible blade and handle used to directly visualize the larynx and facilitate orotracheal intubation, providing a clear line of sight to the vocal cords during airway management procedures. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CCW, regulated under 21 CFR 868.5540, within the Anesthesiology medical specialty. No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    APA Oxy Blade
    Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)
    YEESCOPE LARYNGOSCOPES
    AIRTRAQ SP AIRTRAQ AVANT
    NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET
    TRU-MR LARYNGOSCOPE SET
    MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001
    MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002
    MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002
    FLEXIBLADE
    GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE
    GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE
    SCOPETEX(TM)
    BLUE RIDGE PRODUCTS LARYNGOSCOPE BLADE COVER
    LARYNGOSCOPE COVER
    ILLUMINATOR
    SUNMED'S GREENLINE FIBER OPTIC LARYNGOSCOPE
    AUGUSTINE INTUBATION GUIDE
    CLM LARYNGOSCOPE
    LEIGH MED. TECH. LARYNGOSCOPE BLADE COVER
    KARL STORZ SUBGLOTTISCOPE, NEONATE AND INFANT, FIBER OPTIC LIGHT CARRIER, SUCTION TUBE
    MCINTOSH, MILLER, FOREGGER BABY
    DIRECT VIEW 2001 FIBERLIGHT
    LITE-BLADE
    OPTUS LARYNGOSCOPES
    FIBEROPTIC LARYNGOSCOPE HANDLE
    THE WUSCOPE SYSTEM
    FILLISCOPE
    SUNLITE LARYNGOSCOPE
    SLATER SLEEVE
    LARYNGOSCOPE RIGID
    UPSHERSCOPE(TM)
    AUGUSTINE FIBEROPTIC LARYNGOSCOPE
    AUGUSTINE GUIDE KIT
    BAUMAN DISPOSABLE LARYNGOSCOPE BLADES
    PROPPER LARYNGOSCOPE BLADES W FIBER OPTIC ILLUM.
    AMER PROFILE MILLER LARYNGOSCOPE BLADES, MODIFIED
    AUGUSTINE GUIDE KIT WITH GAUZE SPONGE
    LARYNGOSCOPE
    BELSCOPE LARYNGOSCOPE
    NEUSTEIN LARYNGOSCOPE
    BAUMAN RIGID LARYNGOSCOPE
    MACINTOSH LARYNGOSCOPE BLADES (AMERICAN PROFILE)
    LARYNGOSTAT LARYNGOSCOPE HANDLE
    FIBER OPTIC LARYNGOSCOPE
    BULLARD INTUBATING LARYNGOSCOPE LAR-A & LAR-P
    LARYNGOSCOPE BLADE (ROBERTSHAW STYLE)
    LARYNGOSCOPE
    LARYNGOSCOPE RIGID
    LARYNGOSCOPE BLADES

    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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