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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: CBP FDA class 2

    Valve, Non-Rebreathing

    Anesthesiology

    View full classification →

    The Non-Rebreathing Valve is an anesthesiology device incorporated into a breathing circuit to allow gas to flow in one direction only, preventing the patient from reinhaling exhaled gases and ensuring delivery of fresh gas mixtures during resuscitation or anesthesia. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CBP, regulated under 21 CFR 868.5870, within the Anesthesiology medical specialty. This device is designated as life-sustaining or life-supporting and is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)
    F&P Optiflow Flow Diverter
    Altech® Exhalation Valve (Single Limb and Dual Limb)
    CPR Face Shield
    OJR215 Pressure Relief Manifold
    Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)
    Seal Rite Non-Rebreathing Valve
    KYOLING CPR Mask with Oxygen Port and Without Oxygen Port
    BigEasy Non-Rebreathing Valve
    EXHALATION VALVE
    GENUINE FIRST AID CPR MASK
    AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE
    CPR FACE MASK
    CPR MASK
    PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV 120/140/160; T6 ADAPTER, MODEL T6-100
    OXYGEN DEMAND VALVE
    MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT
    LIV MEDICA CPR FACE MASK
    DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921
    POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A
    MERLIN E-MASK
    BAWMED RESCUE MASK
    PRESSURE MANIFOLD, MODEL BC 110
    MODIFICATION TO HIOX
    LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050
    HI-OX
    Y2000 POCKET RESCUE
    RESUSCI INFLATE-A-SHIELD CPR BARRIER
    RUSCH EMERGENCY MASK
    FACE-2-FACE CPR PROTECTION SHIELD
    AUTO-PEEP MEASUREMENT DEVICE, MODEL # KC 9-P
    EMS MOUTH TO MASK RESUSCITATORS
    EXHALATION VALVE
    EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A)
    RESPAIDE
    RONDEX CPR ISO-SHIELD
    NON-REBREATHING 'T' (BE 117)
    ONE-WAY VALVE (WITH CONNECTOR)
    CPROTECTOR 2000
    SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR
    CPR BIO-BARRIER FACESHEILD
    RESCUE BREATHER
    CPR LIFE MASK COMPACT BARRIER
    MONTGOMERY TRACHEOSTOMY SPEAKING VALVE
    CPR MICROMASK WITH OXYGEN INLET
    SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE
    CPR SUPER POCKET PACK
    CPR MASK & RELATED FAMILY KITS
    CPR MICROMASK
    PERSHIELD CPR DEVICE

    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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