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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: BYE FDA class 2

    Attachment, Breathing, Positive End Expiratory Pressure

    Anesthesiology

    View full classification →

    The Attachment, Breathing, Positive End Expiratory Pressure (PEEP) is an accessory device connected to a ventilator or breathing circuit that maintains a positive pressure in the airway at the end of expiration, improving oxygenation by preventing alveolar collapse in patients with respiratory failure. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BYE, regulated under 21 CFR 868.5965 in the Anesthesiology specialty. This device is designated as life-sustaining or life-supporting.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Besmed PEEP Valve
    DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE
    B&B BUBBLER
    PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES
    O_TWO CPAP SYSTEM
    WATERPAP VALVE
    NEOPIP PATIENT CIRCUIT WITH PEEP
    VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310
    MERCURY CPAP
    BABI*PLUS BUBBLE PAP VALVE
    MERCURY MEDICAL PEEP VALVE
    PULMODYNE CHF FLOW GENERATOR SYSTEM
    NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP
    KOO AMERICAS VALVE PEEP, MODEL KM-809
    BOUSSIGNAC C.P.A.P. DEVICE
    CPAP SYSTEM, MODEL 102001
    WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH
    EMS PEEP VALVES- ADJUSTABLE
    0-20 CM H20 PEEP VALVE
    REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142
    SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
    PEEP VALVE
    WESTMED CIRCULARIE PEP DEVICES
    KENDALL SHERIDAN CPAP SYSTEM
    SIMS CPAP SYSTEM
    SYSTEM 22 VALVE
    PURITAN-BENNETT NASAL CPAP MASK
    SINGLE USE MANUAL RESUSCITATOR PEEP VALVE
    AMBU SINGLE PATIENT USE PEEP VALVE
    PEEP VALVE
    COMPANION 318 NASAL CPAP SYSTEM -- MODIFICATION
    20CM/H20 PEEP VALVE
    CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEM
    ADJUSTABLE PEEP VALVE
    COMPANION 318 NASAL CPAP SYSTEM
    PURITAN BENNETT SINGLE PATIENT USE PEEP VALVE
    PEEP VALVE
    ONE-LUNG CPAP DEVICE
    RESPIRONICS' REMSTAR(TM) SLEEPEASY
    AIRWAY DELIVERY & MANAGEMENT (ADAM) NASAL VENTILA.
    LIFECARE NASAL MASK KIT CAT. NO. 06-800
    C.P.A.P. VALVE AND C.P.P.A. KIT
    DEVILBISS MODEL 7351 SERIES
    CPAP MASK
    DEVILBISS MODEL 7351D REVITALIZER CPAP SYSTEM
    EDENTEC MODEL 2860 PRESSURE METER
    MODIFIED SANDERS BI-PAPEASY
    P.E.E.P. VALVE
    NASAL CPAP SYSTEM
    SULLIVAN NASAL CPAP SYSTEM

    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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