BTO · Tube, Tracheostomy (W/Wo Connector)
Anesthesiology · 21 CFR 868.5800 · Class 2
Overview
| Product Code | BTO |
|---|---|
| Device Name | Tube, Tracheostomy (W/Wo Connector) |
| Regulation | 21 CFR 868.5800 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
| Life-Sustaining | Yes |
Identification
A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 128)
Showing 20 most recent of 128 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242921 | 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 | Vitaltec Corporation | Jun 10, 2025 | SESE |
| K233713 | Pilling Tracheostomy Tubes | Teleflex Medical | Mar 22, 2024 | SESE |
| K192511 | 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 | Venner Medical (Singapore) Pte, Ltd. | Jul 22, 2020 | SESE |
| K173384 | BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube | Smiths Medical Ads, Inc. | Apr 10, 2018 | SESE |
| K120079 | PRIMED TRACHEOSTOMY TUBES (MULTIPLE) | Primed Halberstadt Medizintechnik GmbH | May 24, 2012 | SESE |
| K101721 | WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA | Regulatory and Marketing Services, Inc. | Mar 24, 2011 | SESE |
| K100950 | VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE | Venner Medical (Singapore) Pte, Ltd. | Jul 13, 2010 | SESE |
| K100480 | ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH | Vitaltec Corporation | Jun 11, 2010 | SESE |
| K100283 | VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC | Cook, Inc. | Apr 23, 2010 | SESE |
| K083031 | PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT | Smiths Medical Asd, Inc. | Aug 18, 2009 | SESE |
| K073702 | PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTOR | Lazarus Medical, LLC | Jun 26, 2008 | SESE |
| K062104 | TALKING TRACH | Engineered Medical Systems, Inc. | Apr 20, 2007 | SESE |
| K060945 | PORTEX PERCUTANEOUS TRACHEOSTOMY KIT | Smiths Medical International | Jun 19, 2006 | SESE |
| K051587 | TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470 | Tracoe Medical GmbH | Oct 25, 2005 | SESE |
| K050379 | CS MEDICAL ADULT TTCF CATHETER | Cs Medical, Inc. | Jul 12, 2005 | SESE |
| K042684 | WELL LEAD TRACHEOSTOMY TUBE | Well Lead Medical Instruments | Feb 17, 2005 | SESE |
| K031553 | SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES | Arcadia Medical Corporation | Nov 18, 2003 | SESE |
| K030570 | BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE | Portex , Ltd. | Sep 17, 2003 | SESE |
| K030381 | PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA | Portex , Ltd. | Aug 27, 2003 | SESE |
| K021764 | RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED | Rusch Intl. | Jul 23, 2002 | SESE |
Top Applicants
- Shiley, Inc. — 13 clearances
- Bivona Medical Technologies — 6 clearances
- American Healthcare Corp. — 5 clearances
- Frederic J. Toye, M.D. — 5 clearances
- Hood Laboratories — 4 clearances
