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

    TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL

    K Number: K924191 · Decision Apr 2, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    14
    Review Days
    225

    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
    TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL
    K Number
    K924191
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    American Healthcare Corp.
    Date Received
    August 20, 1992
    Decision Date
    April 2, 1993
    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 American Healthcare Corp.

    K Number Device Name
    K924192 I.V. START KIT (AHC-50-54954
    K923938 IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATER
    K923939 IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER
    K923940 IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE
    K923941 IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE
    K924193 TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685)
    K924195 TRACHEOSTOMY CARE SET W/FORCEPS & GAUZE TRACH DRES
    K924194 TRACHEOSTOMY CARE SET W/EXTRA TOWEL(AHC-20-54686)
    K923834 TRACHEOSTOMY CARE SET WITH GLOVES
    K905136 GAUZE SPONGES, INTERNAL AND EXTERNAL
    Search all 14 clearances from American Healthcare Corp. →