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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: CBK FDA class 2

    Ventilator, Continuous, Facility Use

    Anesthesiology

    View full classification →

    The Continuous Facility-Use Ventilator is an anesthesiology device designed for extended use in clinical facilities to provide continuous mechanical ventilation to patients who cannot breathe adequately on their own, supporting or replacing normal respiratory function. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CBK, regulated under 21 CFR 868.5895, within the Anesthesiology medical specialty. This device is designated as life-sustaining or life-supporting.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Evita (V800); Evita (V600)
    Inbentus Versatile
    VPAP Pediatric Face Mask
    Vivo 45 LS
    F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full
    SV600, SV800 Ventilator
    AVEA disposable expiratory filter/water trap (11790)
    AF531 Oro-Nasal SE Face Mask
    731 Series Ventilator
    Ventoux VC2; Ventoux VC3
    RESPOND(R) Ventilator
    Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask
    Family of DIMAR DMAX NIV masks
    VM-2000
    Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask
    Nihon Kohden NKV-550 Series Ventilator System
    Panther 5
    Mindray SV600 Ventilator, Mindray SV800 Ventilator
    Nihon Kohden NKV-440 Ventilator System
    Evita V800, Evita V600
    Babylog VN800, Babylog VN600
    LTV2 Series Ventilators
    CARESCAPE R860
    Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1
    F&P Visairo NIV Mask Range
    HAMILTON-C3
    Ventway Sparrow
    Hamilton-C6
    Puritan Bennett 980 Series Ventilator System
    Servo-air 4.0 Ventilator System
    Hamilton-G5
    Nihon Kohden NKV-550 Series Ventilator System
    Bellavista
    HAMILTON-T1, HAMILTON-C1
    Hamilton-G5
    Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented
    Trilogy Evo
    Trilogy Evo Universal
    SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1
    Savina 300
    Nihon Kohden NKV-550 Series Ventilator System
    TV-100
    Astral 100/150
    F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version
    Puritan Bennett 980 Ventilator System
    Breathe Technologies Life2000™ Ventilation System
    731 Series Ventilators
    bellavista 1000
    HAMILTON-C3
    VOCSN Unified Respiratory 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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