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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: CAE FDA class 1

    Airway, Oropharyngeal, Anesthesiology

    Anesthesiology

    View full classification →

    The Oropharyngeal Airway is an anesthesiology device inserted into the mouth and throat to maintain an open airway passage, preventing obstruction by the tongue or soft palate during sedation or unconsciousness. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification requirements. The product code is CAE, regulated under 21 CFR 868.5110, within the Anesthesiology medical specialty. No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    LMA FAMILY OF AIRWAYS
    KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305
    KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205
    KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105
    CUFFED OROPHARYNGEAL AIRWAY (COPA)
    RUSCH OPTOSAFE
    KEISEI
    GUEDEL AIRWAY
    STB GUEDEL AIRWAY
    BERMAN AIRWAY
    GUEDEL AIRWAY
    BERMAN INTUBATING/PHARYNGEAL AIRWAY
    INTAVENT LARYNGEAL MASK
    KISS OF LIFE
    GOETTINGER EMERGENCY RESUSCITATION TUBE
    ORAL AIRWAY
    RESPAKIT
    BERMAN TYPE AIRWAY #59422-59429 VARIOUS SIZES
    #400 BROOK AIRWAY & #900 PROFESSIONAL BROOK AIRWAY
    RESUS-AID
    'HILT-WAY' RESUSCITATOR
    THE PROTECTOR
    MODIFIED C.P.R. MICROSHIELD
    RESUSIKIT
    MEDTECH C.P.R. MASK
    DUAL-AID
    DISPOSABLE BERMAN AND GUEDEL AIRWAYS
    DISPOSABLE RESCUE BREATHING DEVICE
    PLASTIC MOUTH BARRIER HCV-E
    RESPIRATORY RESUSCITATION DEVICE
    CURITY FIBEROPTIC INTUBATING AIRWAY
    DISPOSABLE GUEDEL AIRWAY
    PENNINE GUEDEL AIRWAY 00,0,1,2,3 & 4
    RESPIRONICS VENT EASY OXYGEN ENRICHME
    MOUTH TO MASK EMERGENCY VENTILATION
    RES-Q-MATE
    AIRWAY MASKS
    RESPIRONICS RESCUE DOME
    WISDOM AIRWAY
    BROOK LIFE SAVING AIRWAY DEVICE #900 &
    ADJUSTABLE PHARYNGEAL AIRWAY/BERMAN III
    STRAITH ORAL AIRWAY
    WILLIAMS AIRWAY INTUBATOR
    RESCUER
    AIRWAYS
    ESPREE' GUEDEL ESPREE BERMAN AIRWAY
    7CM BERMAN AIRWAY
    RIND AIRWAY
    ORAL AIRWAYS
    THE LUOMANEN ORAL AIRWAY

    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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