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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: BTO FDA class 2

    Tube, Tracheostomy (W/Wo Connector)

    Anesthesiology

    View full classification →

    The Tube, Tracheostomy (W/Wo Connector) is a curved tube inserted through a surgical opening in the neck and into the trachea to establish and maintain a secure airway, used in patients requiring prolonged ventilatory support or airway protection. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is BTO, regulated under 21 CFR 868.5800 in the Anesthesiology specialty. This device is designated as life-sustaining or life-supporting and is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm
    Pilling Tracheostomy Tubes
    Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm
    BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube
    PRIMED TRACHEOSTOMY TUBES (MULTIPLE)
    WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
    VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE
    ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH
    VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC
    PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT
    PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTOR
    TALKING TRACH
    PORTEX PERCUTANEOUS TRACHEOSTOMY KIT
    TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470
    CS MEDICAL ADULT TTCF CATHETER
    WELL LEAD TRACHEOSTOMY TUBE
    SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
    BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE
    PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA
    RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED
    CRICOTHYROTOMY TUBE
    SCOOP 1
    TRANSTRACHEAL CATHETER (ACC. RAVUSSIN).
    CPR TRACHEOTOMY CARE TRAY
    MOORE TRACHEOSTOMY TUBE
    LARKEL DEVICE WITH ATTACHMENTS A-H(MODIFICATION)
    TRACHEOSTOMY CARE KIT
    SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT
    SSV PHONATE(TM) SHILEY SPEAKING VALVE
    TRACHEOSTOMY CARE KIT
    TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685)
    TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL
    TRACHEOSTOMY CARE SET W/EXTRA TOWEL(AHC-20-54686)
    TRACHEOSTOMY CARE SET W/FORCEPS & GAUZE TRACH DRES
    TRACHEOSTOMY CARE SET WITH GLOVES
    CMI STOMA COVERS
    LOW PROFILE TRACHEOSTOMY TUBE
    TRACHEOSTOMY CARE KIT, STERILE, DISPOSABLE
    TRACHEOSTOMY CARE KIT
    BIVONA TRACHEAL T-TUBE STENT
    EMERGENCY PERCUTANEOUS CRICOTHYROIDOTOMY KIT,MODIF
    TRACHEOSTOMY TUBE AND CUFF
    BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE
    D.I.C. TRACHEOSTOMY TUBES & LARYNGECTOMY TUBES
    PRIME CARE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE
    MODIFIED SCOOP TRANSTRACHEAL CATHETERS
    SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN 0.9% SALINE
    SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER
    SHILEY PHONATION VALVE
    STAT-TRACH(TM) VENTILATION CATHETER

    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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