Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5800](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5800) → BTO — Tube, Tracheostomy (W/Wo Connector) # BTO · Tube, Tracheostomy (W/Wo Connector) _Anesthesiology · 21 CFR 868.5800 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO ## Overview - **Product Code:** BTO - **Device Name:** Tube, Tracheostomy (W/Wo Connector) - **Regulation:** [21 CFR 868.5800](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5800) - **Device Class:** 2 - **Review Panel:** [Anesthesiology](/submissions/AN) - **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](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO/K242921.md) | 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](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO/K233713.md) | Pilling Tracheostomy Tubes | Teleflex Medical | Mar 22, 2024 | SESE | | [K192511](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO/K192511.md) | 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](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO/K173384.md) | 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](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO/K120079.md) | PRIMED TRACHEOSTOMY TUBES (MULTIPLE) | Primed Halberstadt Medizintechnik GmbH | May 24, 2012 | SESE | | [K101721](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO/K101721.md) | WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA | Regulatory and Marketing Services, Inc. | Mar 24, 2011 | SESE | | [K100950](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO/K100950.md) | VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE | Venner Medical (Singapore) Pte, Ltd. | Jul 13, 2010 | SESE | | [K100480](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO/K100480.md) | ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH | Vitaltec Corporation | Jun 11, 2010 | SESE | | [K100283](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO/K100283.md) | VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC | Cook, Inc. | Apr 23, 2010 | SESE | | [K083031](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO/K083031.md) | PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT | Smiths Medical Asd, Inc. | Aug 18, 2009 | SESE | | [K073702](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO/K073702.md) | PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTOR | Lazarus Medical, LLC | Jun 26, 2008 | SESE | | [K062104](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO/K062104.md) | TALKING TRACH | Engineered Medical Systems, Inc. | Apr 20, 2007 | SESE | | [K060945](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO/K060945.md) | PORTEX PERCUTANEOUS TRACHEOSTOMY KIT | Smiths Medical International | Jun 19, 2006 | SESE | | [K051587](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO/K051587.md) | TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470 | Tracoe Medical GmbH | Oct 25, 2005 | SESE | | [K050379](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO/K050379.md) | CS MEDICAL ADULT TTCF CATHETER | Cs Medical, Inc. | Jul 12, 2005 | SESE | | [K042684](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO/K042684.md) | WELL LEAD TRACHEOSTOMY TUBE | Well Lead Medical Instruments | Feb 17, 2005 | SESE | | [K031553](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO/K031553.md) | SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES | Arcadia Medical Corporation | Nov 18, 2003 | SESE | | [K030570](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO/K030570.md) | BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE | Portex , Ltd. | Sep 17, 2003 | SESE | | [K030381](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO/K030381.md) | PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA | Portex , Ltd. | Aug 27, 2003 | SESE | | [K021764](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO/K021764.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTO) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com