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510(k) Data Aggregation

    K Number
    K242921
    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
    Manufacturer
    Vitaltec Corporation
    Date Cleared
    2025-06-10

    (259 days)

    Product Code
    BTO
    Regulation Number
    868.5800
    Why did this record match?
    Product Code :

    BTO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Rota-Trach Disposable Standard Tracheostomy Tube is indicated for airway maintenance of tracheostomized patients.
    Device Description
    Rota-Trach Disposable Standard Tracheostomy Tube is a respiratory device inserted into the patient's trachea through a stoma, making direct contact with the tracheal mucosal membrane tissue. It may be with or without a cuff attaching around the tube of the device. The design of the cuff could seal the space between the tube and the patient's trachea from inhaling undesired or foreign matters and for assistance of positive pressure ventilation.
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    K Number
    K233713
    Device Name
    Pilling Tracheostomy Tubes
    Manufacturer
    Teleflex Medical
    Date Cleared
    2024-03-22

    (123 days)

    Product Code
    BTO
    Regulation Number
    868.5800
    Why did this record match?
    Product Code :

    BTO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tracheostomy tubes are intended to provide tracheal access for airway management of tracheostomized patients.
    Device Description
    Pilling™ Tracheostomy Tubes are stainless-steel tracheostomy tubes that are intended to provide tracheal access for airway management of tracheostomized patients. The tracheostomy tubes are reusable, single-patient devices that are provided non-sterile, and intended to be cleaned prior to initial use. Each tube consists of an outer cannula, inner cannula, and pilot/obturator. The inner and outer tubes fit closely to provide maximum airway. The distal edge of the inner tube is flush with, and fits very closely to, that of the outer tube to allow for complete cleaning. Variations in diameter, shape of the inner and outer tubes (radius of curvature), locking mechanism, and neck plate configurations are the basis of the various styles available. The tubes are available in sizes ranging from 00 (4.5mm outside diameter, 2.4mm inside diameter) to 12 (16.3mm outside diameter. 12.7mm inside diameter) based on individual style. Insertable lengths range from 33mm (size 00) to 85mm (size 9 Extra Long) based on individual style. Shape of the device and specific design of the neck plate and locking feature is based on style (Jackson, Jackson Improved, and Mayo). Some Pilling™ Tracheostomy Tubes are fenestrated to facilitate speech and all tubes can be fenestrated upon request. Certain inner tubes are compatible with the Shikani-French Speaking Valve (Product Code JOH, 510(k) K982128). Pilling™ Tracheostomy Tubes are available in models with or without permanently attached 15mm adapters.
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    K Number
    K192511
    Device Name
    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
    Manufacturer
    Venner Medical (Singapore) PTE Ltd
    Date Cleared
    2020-07-22

    (314 days)

    Product Code
    BTO
    Regulation Number
    868.5800
    Why did this record match?
    Product Code :

    BTO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Venner PneuX™ TT (Tracheostomy Tube) is intended to be inserted into the patient's tracheostomy stoma during extended periods (not more than 30 days) of intensive or critical care to facilitate ventilation and for the evacuation or drainage of secretions from the subglottic space.
    Device Description
    The Venner Pneux TT (Tracheostomy Tube) is a disposable, sterile, single-patient, single-use device. It is a flexible, low volume and low pressure cuffed tracheostomy tube, which is reinforced with a Nitinol wire. The Venner PneuX TT may be used with the Venner PneuX TSM™ to monitor, maintain and regulate cuff pressure. The Venner PneuX TSM was cleared for marketing via 510(k) application K110631. The Venner PneuX TT is available in three sizes (inner diameters: 7.0, 8.0 and 9.0 mm) and is MRI Conditional. Depth markings indicate the distance to the distal tip of the tube and a printed black line provides a means to orient the tube. The device provides access to subglottic space by having three additional lumens running along the airway lumen. The three lumens are integrated into the tube wall ending just above the proximal end of the cuff for ease of suction. Connected to the suction tube and subglottic connector, it allows intermittent suctioning of secretions from the subglottic space, and irrigation. A winged tube holder allows for securement with openings on each end for a head/neck strap to pass through. A fixation block secures the position of the tube to preventunintended movement during use. A standard connector (15 mm) for universal attachment to a ventilator is present, as well as an inflation line to connect the cuff for inflation and deflation. A pilot balloon connects the cuff to provide an indication of the pressure within the cuff and the pilot valve opens to allow free flow of air to the cuff for inflation when a Luer lock syringe is engaged. When the syringe is removed, the valve closes to prevent leakage of air and ensures the cuff is inflated. The obturator fits in the airway tube of the TT and guides its placement. Its tip is designed to aid passage through the surgical opening of a tracheostomy stoma. The obturator also has a hole which allows a guidewire to pass through, if clinically required.
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    K Number
    K173384
    Device Name
    BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube
    Manufacturer
    Smiths Medical ADS, Inc.
    Date Cleared
    2018-04-10

    (162 days)

    Product Code
    BTO
    Regulation Number
    868.5800
    Why did this record match?
    Product Code :

    BTO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Smiths Medical Portex® BLUselect® Tracheostomy Tube is indicated for airway maintenance of tracheostomised patients. Smiths Medical Portex® BLUselect® Suctionaid® Tracheostomy Tube is indicated for airway maintenance of tracheostomised patients. Suctionaid® allows aspiration of contaminated mucous and subglottic secretions that collect and build up between the tracheostomy tube cuff and the glottis. The BLUselect® Inner Cannula is intended to be used with the Smiths Medical Portex® BLUselect® Tracheostomy Tube indicated for airway maintenance of tracheostomy patients.
    Device Description
    The Smiths Medical Portex® BLUselect and BLUselect Suctionaid Tracheostomy Tubes are designed to aid the adult population who require an artificial airway due to trauma or medical condition. Patients who benefit from this procedure are those who: require prolonged intubation for mechanical ventilator support; cannot manage their airway secretions; or have an upper airway obstruction. BLUselect Inner Cannula is intended to be used with the Smiths Medical Portex® BLUselect Tracheostomy Tubes. The subject device package consists of a tracheostomy tube, a tube holder, cleaning brush, an inner cannula, obturator, disconnection wedge, and a vacuum control valve (with Suctionaid® tubes only) and a maximum recommended period of use is 29 days; intended to be used critical care settings, acute care settings, long term care facilities, and for home use. The tube is manufactured with a flange, inflation line, suction line and a 15mm connector. All components are manufactured from medical grade materials and have biocompatibility data for safe use when in-contact with patient tissue/bodily fluids/secretions.
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    K Number
    K120079
    Device Name
    PRIMED TRACHEOSTOMY TUBES (MULTIPLE)
    Manufacturer
    PRIMED HALBERSTADT MEDIZINTECHNIK GMBH
    Date Cleared
    2012-05-24

    (135 days)

    Product Code
    BTO
    Regulation Number
    868.5800
    Why did this record match?
    Product Code :

    BTO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Primed Tracheostomy Tubes are intended to provide tracheal access for airway management of tracheostomized patients.
    Device Description
    The Primed Tracheostomy Tubes consists of various types of tracheostomy tubes, e.g., Primedistom Cannulas w/wo cuff, Silver Cannulas, Priflex Cannulas, Silicone Cannulas (Primedi Silk), and Primedi Star Cannulas. The tracheostomy tubes are made of different materials and offer a variety of inner and outer diameters and varying lengths thus making it possible to meet the individual needs of a patient. The Primed Tracheostomy Tubes can be obtained sieved or unsieved, with or without speaking valve, cuffed or uncuffed, with or without one or two inner cannulas. The accessories comprise different speaking valves as well as Humid Moist Exchangers (HME) and different types of filters.
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    K Number
    K101721
    Device Name
    WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
    Manufacturer
    REGULATORY AND MARKETING SERVICES, INC.
    Date Cleared
    2011-03-24

    (279 days)

    Product Code
    BTO
    Regulation Number
    868.5800
    Why did this record match?
    Product Code :

    BTO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Well lead Tracheostomy Tubes and Disposable Inner Cannula is a single patient disposable tracheostomy tube for airway management of tracheostomotized patients.
    Device Description
    The Well lead Tracheostomy Tubes and Disposable Inner Cannula includes an outer cannula, disposable inner cannula, introducer, neck strap and obturator. The disposable inner cannula acts as a removable liner for the outer tube; it can be withdrawn and changed after the airway has been cleaned, such as phlegm suction. The disposable inner cannula facilitates the airway management to make it easy to clean and prolong the use of the device. The device is used to provide an artificial airway in order to provide access to the patient's airway for airway management. The device is introduced into a tracheotomy incision in the patient's neck that provides access to the trachea. The tracheostomy tube is secured by the means of the swivel neck plate/flange. When appropriately connected the device provides a secure artificial airway for spontaneous or mechanical ventilation.
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    K Number
    K100950
    Device Name
    VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE
    Manufacturer
    VENNER MEDICAL (SINGAPORE) PTE LTD
    Date Cleared
    2010-07-13

    (98 days)

    Product Code
    BTO
    Regulation Number
    868.5800
    Why did this record match?
    Product Code :

    BTO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Venner PneuxP. Y.TM Tracheostomy Tube (TT) is a tracheostomy tube intended to be inserted into the patient's trachea via a tracheostomy stoma during extended periods (not more than 30 days) of intensive or critical care to facilitate ventiliation and for evacuation or drainage of secretion from the subglottice space.
    Device Description
    Venner Pneux P.Y.TM TracheostomyTube
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    K Number
    K100480
    Device Name
    ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH
    Manufacturer
    VITALTEC CORPORATION
    Date Cleared
    2010-06-11

    (113 days)

    Product Code
    BTO
    Regulation Number
    868.5800
    Why did this record match?
    Product Code :

    BTO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tracheostomy Tubes are intended for use in providing direct tracheal access for airway management.
    Device Description
    The VITALTEC Rota-Trach Tracheostomy Tubes are made from the raw material of The VITALIEC Kota Track Track Tracksonsyland of connector and valve. The the seeff with Sincolle for medical ass, while the components of the propriate hardness, the cuff with tubes have such good perfectionsment tube and excellent biocompatibility.
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    K Number
    K100283
    Device Name
    VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC
    Manufacturer
    COOK, INC.
    Date Cleared
    2010-04-23

    (81 days)

    Product Code
    BTO, VER
    Regulation Number
    868.5800
    Why did this record match?
    Product Code :

    BTO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VersaTube™ Tapered Tracheostomy Tube is intended to provide an artificial airway to establish airway patency and to provide maintenance of the airway.
    Device Description
    The VersaTube is a sterile, single use cuffed tracheostomy tube with a disposable inner cannula, and will be manufactured as a 7, 8, or 9 mm ID device (with the inner cannula being either 6, 7, or 8 mm ID). The angle of curvature of the VersaTube is 96° (7, 8 mm ID) or 97 ° (9 mm ID) and ranges from 78 to 98 mm. The neck-plate, 15 mm airway connector, and inner cannula are color coded to marry together the tracheostomy tube with the correctly sized inner cannula. The device is not intended to be used for more than 29 days. The VersaTube consists of a polyviny1 chloride outer cannula which is tapered at the distal end for smooth insertion. The device also incorporates a low pressure, high volume balloon cuff at the distal end of the device for the purpose of sealing the airway for proper ventilation. Included with the VersaTube are two inner cannulae. Each inner cannula is designed for a close fit to the corresponding size VersaTube.
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    K Number
    K083031
    Device Name
    PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Date Cleared
    2009-08-18

    (312 days)

    Product Code
    BTO
    Regulation Number
    868.5800
    Why did this record match?
    Product Code :

    BTO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Portex ® UniPerc™ single use Percutaneous Dilation Tracheostomy (PDT) Kits allows the controlled, elective subcricoid perculaneous insertion of an adjustable flange tracheostomy tube for airway management using a Seldings guidewire dilation technique in patients with a large neck and manimum of 50mm of pre-tracheal soft tissue in to the trachea) where standard (up to a maximum of S0mm of pre-tracheal soft tissue anterior to the trached on go noon anatomy (up to a maximum of pre-traches to the trachea) where standard length flange tracheostomy tubes are too short. Tracheostomy tube maximum period of use 29 days.
    Device Description
    The UniPerc™ device has been designed to facilitate percutaneous tracheostomy in patients with a large neck mass and a consequently large skin to anterior trachea depth. The UniPerc™ device is centered on an extra length, wire reinforced, pre-curved, cuffed or uncuffed, tracheostomy tube mounted with an adjustable flange. The tube is supplied with an inner cannula, which can be used to line the internal surface of the tube. Obturators, dilators and other parts are supplied with the various kits. The UniPerc™ device is designed for insertion using existing, dilating percutaneous or surgical insertion techniques. Care of the device whilst in use also follows existing standards techniques. The graduated single stage dilator has a lubricious hydrophilic coating when wetted, to improve its ease of insertion.
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