BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ENDOTRACHEAL TUBE

    K Number: K772138 · Decision Dec 20, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    238
    Review Days
    36

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ENDOTRACHEAL TUBE
    K Number
    K772138
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Medline Industries, Inc.
    Date Received
    November 14, 1977
    Decision Date
    December 20, 1977
    Product Code
    BTO
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BTO Tube, Tracheostomy (W/Wo Connector)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (BTO), ordered by most recent decision date.

    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

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Pilling Tracheostomy Tubes

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    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

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PRIMED TRACHEOSTOMY TUBES (MULTIPLE)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA

    FDA 510(k)
    FDA Class 2 ·Anesthesiology
    View all

    Other Clearances by Medline Industries, Inc.

    K Number Device Name
    DEN210049 Medline ART Skin Harvesting System
    K230559 Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)
    K223100 Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)
    K222665 Medline UNITE® Ankle Fusion Plating System
    K213054 Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe
    K212911 Konig Mogen Clamp
    K220565 Hudson RCI Triflo II Incentive Deep Breathing Exerciser
    K213481 Medline General Surgery Tray
    K212093 Medline Universal Grounding Pad
    K213068 Medline Smoke Evacuation Shroud
    Search all 238 clearances from Medline Industries, Inc. →