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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: CBH FDA class 1

    Device, Fixation, Tracheal Tube

    Anesthesiology

    View full classification →

    The Tracheal Tube Fixation Device is an anesthesiology device used to secure an endotracheal tube in position after insertion, preventing unintentional displacement or movement of the tube that could compromise airway management. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CBH, regulated under 21 CFR 868.5770, within the Anesthesiology medical specialty. No special flags apply to this device.

    510(k) Clearances

    47 matches
    K Number
    Device Name
    AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM
    DALE ENDOTRACHEAL TUBE HOLDER 270/280
    HCI TUBE STABILIZER
    DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS
    TRACHE-TITE
    FLEX BLUE
    ENDOTRACHEAL TUBE HOLDER
    HOLDE.T. ENDOTRACHEAL TUBE STABILIZATION BAR
    TRACH TIE, VENTILATOR TUBING HOLDER
    TRAKEEZ
    NETOH ENDOTRACHEAL TUBE HOLDER
    PREPARE LOCK
    STABILTRACH
    BREATHING TUBE SUPPORT
    ANTI-DISCONNECTION MECHANISM
    ADHESIVE E.T. TAPE
    ENDO TRACHEA TUBE FIXATION
    CN ENDOTRACHEAL TUBE HOLDER
    AGA TRACH TIES
    THE LEWIS TUBE HOLDER
    E.T. TAPE II
    DALE VENTILATOR TUBING SUPPORT FOR TRACH. VENT.
    TRACH COLLAR
    SALTER LABS MODEL #1015
    49-610 NIKO-NOSE FIXATION TAPE
    BLAKE MEDICAL BREATHING TUBE SUPPORT
    BABY E.T. TAPE II
    E.T. TAPE II
    NASAL E.T. TAPE
    ET-RESTRAINT CAT. # ER 4000
    A.C.I. TRACH TIE
    RESPIRONIC'S INFANT SECUREEASY
    FIXATION DEVICE, TRACH TUBE
    TRACH COLLAR
    TRAKEFIT TRACHEOSTOMY TUBE HOLDER
    BABY E.T. TAPE(TM)
    ENDOTRACHEAL TUBE HOLDER
    E. T. TAPE ENDOTRACHEAL TUBE HOLDER
    RESPIRONICS SECUREASY
    OR TUBE RESTRAINT
    TRACHEAL TUBE FIXATION DEVICE
    E.T. STRAP #6000
    RESPIRONICS ENDO TUBE CONTROL SYS
    N-D0-SURE
    ENDOTRACHEAL TUBE HOLDER
    ENDOTRACHEAL TUBE HOLDER
    LUBE-LOK

    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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