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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: BYG FDA class 1

    Mask, Oxygen

    Anesthesiology

    View full classification →

    The Mask, Oxygen is a face mask applied over the nose and mouth to deliver supplemental oxygen to spontaneously breathing patients who require increased inspired oxygen concentrations. It is classified as FDA Class 1, the lowest risk category, subject to general controls only with no premarket submission required. The product code is BYG, regulated under 21 CFR 868.5580 in the Anesthesiology specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    FIRST AID KIT(S)
    HANS RUDOLPH NASAL CPAP MASK
    DISPOSABLE, CPAP OXYGEN MASK
    WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK
    VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS
    WESTMED PEDIATRIC AND ADULT AEROSOL MASK
    JEMSDAL MASK
    SYSTEM 22 PAEDIATRIC MASK
    SYSTEM 22 ADULT MASK
    MEDWAY OXYGEN MASK
    SURGICO OXYGEN MASK
    SEAL RING FOR NASAL CPAP
    TRACHEOSTOMY MASK
    OXYGEN MASKS 81420, 81421, 81471 & 81461
    VENTURI OXYGEN MASK
    OXYGEN MASKS 82400 & 82405
    SALTER LABS INFANT MEDIUM CONCENTRATION MASK
    ANESTHESIA/RESPIRATORY FACE MASK, VARIOUS SIZES
    DISPOSABLE FACE MASK
    DISPOSABLE FACE MASK
    DISPOSABLE FACE MASK
    SLEEPAP MASK
    KENDALL CURITY OXYGEN MASK
    SINGLE PATIENT USE NASAL (CPAP) CIRCUIT
    MASK, OXYGEN
    CRYSTAL MASK
    SALTER LABS #4004/4104 OXYGEN MASK W/C02 SAMP LINE
    TRACHEOSTOMY MASKS/ADULT & PAEDIATRIC
    AEROSOL MASKS/ADULT & PAEDIATRIC
    MEDIUM CONCENTRATION OXYGEN MASKS
    OXY-TWO
    AERO-MASK ONE
    OXY-ONE
    AERO-MASK TWO
    CARNATION - OXYGEN MASK
    CARNATION OXYGEN
    STOCK #64091-PEDIATRIC OXYGEN MASK
    OXYGEN MASKS
    NASAL OXYGEN CANNULA OXYGEN MASK
    PEDIATRIC OXYGEN MASKS
    ADULT MASKS & PEDIATRIC MASKS
    PEDIATRIC OXYGEN OR AEROSOL MASKS,
    PEEP FACE MASK
    OXYGEN BARB M-552
    OXYGEN MASK, ADULT VINYL
    AEROSOL MASK
    OXYGEN MASK REBREATHER
    OXYGEN MASK-HIGH CONCENTRATION
    MASK, BI FLO NASAL OXYGEN
    FACE TENTS

    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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