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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: BYI FDA class 2

    Percussor, Powered-Electric

    Anesthesiology

    View full classification →

    The Percussor, Powered-Electric is an electrically powered device that delivers rhythmic mechanical percussion to the chest wall to mobilize and loosen pulmonary secretions, facilitating their clearance in patients with respiratory conditions such as cystic fibrosis or chronic obstructive pulmonary disease. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BYI, regulated under 21 CFR 868.5665 in the Anesthesiology specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    LibAirty Airway Clearance System
    Respiratory Muscle Trainer
    The Vest APX System (PVAPX1)
    Electromed SmartVest Airway Clearance System
    Electro Flo 6 Airway Clearance System
    AirPhysio Positive Expiratory Pressure (PEP) Device
    Monarch Airway Clearance System
    Monarch Airway Clearance System
    The Vest Airway Clearance System
    SMARTVEST AIRWAY CLEARANCE SYSTEM
    BREATH SHAKE
    INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST
    RESIN 11
    FREQUENCER
    FREQUENCER MODEL V2X
    FREQUENCER, MODEL 1001
    LUNG FLUTE
    SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL
    THE INCOURAGE SYSTEM
    MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000EZ
    ELECTRO FLO PERCUSSOR, MODEL 5000
    THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104
    ABI VEST AIRWAY CLEARANCE SYSTEM
    ABI VEST AIRWAY CLEARANCE SYSTEM
    MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000
    X-AIR-CISER
    FLUTTER D
    THAIRAPY VEST SYSTEM
    FLUTTER(R)
    3P (PULMONARY PERCUSSIVE PACK)
    THAIRAPY SYSTEM
    FLUTTER(R)
    EMS PERCUSSOR
    MJ PERCUSSOR(TM)
    FLEX-CUP PERCUSSOR
    PULMO-PATTY
    THAIRAPY(TM) BRONCHIAL DRAINAGE SYSTEM, MODEL 101
    MANUAL PERCUSSOR CUPS
    THUMPER MODEL P-1000
    SALTER LABS 3000 SERIES PERCUSSORS
    NEONATE PERCUSSOR
    NEOCUSSOR (MASSAGER, BATTERY) POWERED
    NEOGUARD CHEST PERCUSSOR
    INFANT PERCUSSOR PA-010
    PNEUMOPULSSOR (PPS II)
    PNEUMO PULSSOR III
    PNEUMO PULSSOR
    INFANT PERCUSSOR #5534
    MJ NEONATAL PERCUSSOR
    PERCUSSOR

    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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