BTO — Tube, Tracheostomy (W/Wo Connector) Class II
FDA product code BTO covers "Tube, Tracheostomy (W/Wo Connector)", a Class II medical device regulated under 21 CFR 868.5800. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- BTO
- Device Class
- Class II
- Regulation Number
- 868.5800
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242921 | vitaltec corporation | 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes | June 10, 2025 |
| K233713 | teleflex medical | Pilling Tracheostomy Tubes | March 22, 2024 |
| K192511 | venner medical (singapore) pte | Venner PneuX TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX TT (Tracheostomy | July 22, 2020 |
| K173384 | smiths medical ads | BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestr | April 10, 2018 |
| K120079 | primed halberstadt medizintechnik | PRIMED TRACHEOSTOMY TUBES (MULTIPLE) | May 24, 2012 |
| K101721 | regulatory and marketing services | WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA | March 24, 2011 |
| K100950 | venner medical (singapore) pte | VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE | July 13, 2010 |
| K100480 | vitaltec corporation | ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH | June 11, 2010 |
| K100283 | cook | VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PRE | April 23, 2010 |
| K083031 | smiths medical asd | PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT | August 18, 2009 |
| K073702 | lazarus medical | PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTOR | June 26, 2008 |
| K062104 | engineered medical systems | TALKING TRACH | April 20, 2007 |
| K060945 | smiths medical international | PORTEX PERCUTANEOUS TRACHEOSTOMY KIT | June 19, 2006 |
| K051587 | tracoe medical | TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, | October 25, 2005 |
| K050379 | cs medical | CS MEDICAL ADULT TTCF CATHETER | July 12, 2005 |
| K042684 | well lead medical instruments | WELL LEAD TRACHEOSTOMY TUBE | February 17, 2005 |
| K031553 | arcadia medical corporation | SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC | November 18, 2003 |
| K030570 | portex | BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE | September 17, 2003 |
| K030381 | portex | PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA | August 27, 2003 |
| K021764 | rusch intl | RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED | July 23, 2002 |