BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT

    K Number: K083031 · Decision Aug 18, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    52
    Review Days
    312

    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
    PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT
    K Number
    K083031
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smiths Medical Asd, Inc.
    Date Received
    October 10, 2008
    Decision Date
    August 18, 2009
    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 Smiths Medical Asd, Inc.

    K Number Device Name
    K232943 Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe
    K210833 Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula
    K211634 Hypodermic Needle-Pro EDGE Safety Device
    K192375 Intellifuse Administration and Intellifuse Blood Administration Sets
    K181699 Level 1 Convective Warmer
    K172800 Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors
    K172823 Portex NRFit Epidural Needles
    K172410 Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters
    K172592 CADD Yellow High Volume Administration Set with NRFit connector
    K173912 BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube
    Search all 52 clearances from Smiths Medical Asd, Inc. →