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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: CAP FDA class 2

    Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

    Anesthesiology

    View full classification →

    The Airway Pressure Monitor, which may include both a gauge and an alarm, is an anesthesiology device that continuously measures and displays the pressure within a patient's breathing circuit during mechanical ventilation or anesthesia, alerting clinicians to unsafe pressure levels. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CAP, regulated under 21 CFR 868.2600, within the Anesthesiology medical specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    SINGLE USE MANOMETER
    VORTRAN APM-Plus
    NS 120P-TRS Airway Pressure Gauge
    NAPA LP-15 Airway Pressure Monitor
    VORTRAN Manometer
    Disposable Pressure Manometer (DPM)
    DISPOSABLE PRESSURE MANOMETER
    GIO DIGITAL PRESSURE GUAGES
    MANOMETER
    VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER
    VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC
    PRESSURE MANOMETER
    VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0
    NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS
    PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000
    AMBU DISPOSABLE PRESSURE MANOMETER
    DISPOSABLE PRESSURE MANOMETER
    DISPOSABLE PRESSURE MONITOR
    CRITERION 60 OR PM 60
    CRITERION 40 OR PM 40
    TSX PRM PULMONARY RESUSCITATION MONITOR
    1ST RESPONSE DISPOSABLE MANOMETER
    MERCURY AIRWAY PRESSURE MANOMETER
    AMS 3000M
    PORTA-RESP MONITOR
    MICRO MPM
    CM7000 REMOTE INDICATOR
    CM5000R REMOTE INDICATOR
    AIRWAY PRESSURE MONITOR CM 5000 NGAN
    BREATH TRACKER(TM) MODEL 1800 CAN-O-GAUGE
    RESPIRONICS' DIGITAL MANOMETER
    RESPIRONICS BIPAP PRESSURE ALARM (BIPAP P.A.)
    PENLON BREATHING SYSTEM PRESSURE MONITOR
    INFANT C.P.A.P. MONITOR
    VENTILARM II PORTABLE AIRWAY PRESSURE MONITOR
    LIFECARE PRESSURE ALARM CAT. NO. 34-010
    PENLON IDP PRESSURE FAILURE ALARM
    BREATH TRACKER
    CM 7000MR
    CM 5000R REMOTE AIRWAY PRESSURE
    M-1 PRESSURE MONITOR
    M-10 VENTILATION MONITOR
    CM 5000 MONITOR AIRWAY PRESSURE
    OHMEDA 5500 AIRWAY PRESSURE MONITOR
    MODIFIED BAROMED BREATHING PRESSURE MONITOR
    SECHRIST AIRWAY PRESSURE MONITOR MODEL 600
    VENTILATOR PRESSURE ALARM MODEL VPA-100
    PMA PRESSURE MONITOR
    AN PRESSURE MONITOR
    LPA-2 REMOTE ALARM

    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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