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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: BSJ FDA class 1

    Mask, Gas, Anesthetic

    Anesthesiology

    View full classification →

    The Mask, Gas, Anesthetic is a face mask used to deliver anesthetic gases and oxygen to a patient during the induction or maintenance of general anesthesia, creating a sealed interface over the nose and mouth. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is BSJ, regulated under 21 CFR 868.5550 in the Anesthesiology specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    SuperNO2VA Device
    ANESTHESIA/RESPIRATORY FACE MASK
    ANESTHESIA FACE MASK
    BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK
    AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK
    DISPOSABLE ADHESIVE FACE MASK
    MASK, GAS, ANESTHETIC
    DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK
    DISPOSABLE, PREFORMED FACE MASK
    NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONE
    AMBU DISPOSABLE FACE MASK
    IAS ANESTHESIA MASK
    VENTLAB VENT-MASK, CAT# VR 0010/20/30
    ORAL-NASAL MASK RESUSCITATION AND ANESTHETIC GAS
    MODIFIED TOUCH-ME-NOT MASK
    ANESTHESIA/RESPIRATORY DISPOSABLE MASK
    RESPIRONICS SEALEASY II
    MODIFIED CUSHION-FLEX(TM)
    CUSHION FLEX(TM)
    MASK, GAS, ANESTHETIC
    RONDEX RESCUE MASK
    NON CONDUCTIVE, SINGLE USE ANESTHESIA FACE MASK
    MASK, ANESTH. INFLATABLE & PEDIATRIC SCENTED, DISP
    SEALFLEX MASK
    SPIRASEAL(TM) FACE MASK (VARIOUS SIZES)
    RIBBED CUSHION MASK
    MP-XMV DISPOSABLE FACE MASK
    MP-XML DISPOSABLE FACE MASK
    MP-XMO DISPOSABLE FACE MASK
    MP-XMM DISPOSABLE FACE MASK
    FACEGLOV,ANESTHETIC GAS MASK
    SERIES 2000 MEDS MASK
    SUR-FIT FACE MASK
    PEDIATRIC ANESTHESIA MASK W/PACIFIER/RING ASSEMBLY
    MEDIPART FACE MASK MP-XM
    MEDIPART FACE MASK & FILTER MP-30XM
    CUSHION-FLEX TM
    DRYDEN INFLATABLE MASK
    DISPOSABLE ANESTHESIA MASK
    DISPOS. ANESTHESIA FACE MASK
    PREMIUM DABM DISPOS. ANES. BREATH MASK
    CRYSTALCONE FACE MASK-MED-W/HOOKRING
    PAEDIATRIC FACE MASK 1-3 W/WO RING
    NON CONDUCTIVE ANESTHESIA FACEMASK
    MASKS
    NON CONDUCTIVE PEDIATRIC ANES. FACE
    OHIO NONCONDUCTIVE RBS TYPE FACE MASK
    NON-CONDUCTIVE ANESTHESIA FACE MASK
    NON-CONDUCTIVE, SINGLE USE FACE MASK #55
    ACCUTRON POLLUTION REDUCER

    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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