FDA 510(k) Applications for Medical Device Product Code "BTO"
(Tube, Tracheostomy (W/Wo Connector))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K031553 | ARCADIA MEDICAL CORPORATION | SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES | 11/18/2003 |
| K962240 | BOSTON MEDICAL PRODUCTS, INC. | MOORE TRACHEOSTOMY TUBE | 08/15/1996 |
| K100283 | COOK, INC. | VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC | 04/23/2010 |
| K050379 | CS MEDICAL INC. | CS MEDICAL ADULT TTCF CATHETER | 07/12/2005 |
| K960205 | CUSTOM PACK RELIABILITY | CPR TRACHEOTOMY CARE TRAY | 08/27/1996 |
| K062104 | ENGINEERED MEDICAL SYSTEMS, INC. | TALKING TRACH | 04/20/2007 |
| K073702 | LAZARUS MEDICAL LLC | PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTOR | 06/26/2008 |
| K983000 | POLAMEDCO, INC. | CRICOTHYROTOMY TUBE | 10/27/1999 |
| K030570 | PORTEX LTD. | BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE | 09/17/2003 |
| K030381 | PORTEX LTD. | PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA | 08/27/2003 |
| K120079 | PRIMED HALBERSTADT MEDIZINTECHNIK GMBH | PRIMED TRACHEOSTOMY TUBES (MULTIPLE) | 05/24/2012 |
| K101721 | REGULATORY AND MARKETING SERVICES, INC. | WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA | 03/24/2011 |
| K021764 | RUSCH INTL. | RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED | 07/23/2002 |
| K953559 | SEIDEL MEDIZIN GMBH | LARKEL DEVICE WITH ATTACHMENTS A-H(MODIFICATION) | 05/16/1996 |
| K173384 | Smiths Medical ADS, Inc. | BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube | 04/10/2018 |
| K083031 | SMITHS MEDICAL ASD, INC. | PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT | 08/18/2009 |
| K060945 | SMITHS MEDICAL INTERNATIONAL | PORTEX PERCUTANEOUS TRACHEOSTOMY KIT | 06/19/2006 |
| K233713 | Teleflex Medical | Pilling Tracheostomy Tubes | 03/22/2024 |
| K051587 | TRACOE MEDICAL GMBH | TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470 | 10/25/2005 |
| K981080 | TRANSTRACHEAL SYSTEMS | SCOOP 1 | 06/17/1998 |
| K955461 | VBM MEDIZINTECHNIK GMBH | TRANSTRACHEAL CATHETER (ACC. RAVUSSIN). | 03/19/1997 |
| K100950 | VENNER MEDICAL (SINGAPORE) PTE LTD | VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE | 07/13/2010 |
| K192511 | Venner Medical (Singapore) PTE Ltd | Venner PneuXÖ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuXÖ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuXÖ TT (Tracheostomy Tube) Size 9.0 mm | 07/22/2020 |
| K242921 | Vitaltec Corporation | 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 Tracheostom | 06/10/2025 |
| K100480 | VITALTEC CORPORATION | ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH | 06/11/2010 |
| K042684 | WELL LEAD MEDICAL INSTRUMENTS | WELL LEAD TRACHEOSTOMY TUBE | 02/17/2005 |
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