Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5730](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5730) → BTR — Tube, Tracheal (W/Wo Connector) # BTR · Tube, Tracheal (W/Wo Connector) _Anesthesiology · 21 CFR 868.5730 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTR ## Overview - **Product Code:** BTR - **Device Name:** Tube, Tracheal (W/Wo Connector) - **Regulation:** [21 CFR 868.5730](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5730) - **Device Class:** 2 - **Review Panel:** [Anesthesiology](/submissions/AN) - **Life-sustaining:** yes ## Identification A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 240) Showing 20 most recent of 240 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K250173](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTR/K250173.md) | Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR) | Covidien, LLC | Oct 6, 2025 | SESE | | [K243785](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTR/K243785.md) | Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless Reinforced | Covidien, LLC | Sep 25, 2025 | SESE | | [K243579](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTR/K243579.md) | AeroJet Ventilation Catheter | Pipeline Medical Products, LLC | Aug 13, 2025 | SESE | | [K251499](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTR/K251499.md) | Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS) | William Cook Europe Aps | Jun 11, 2025 | SESE | | [K250243](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTR/K250243.md) | ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U) | Flexicare Medical Limited. | May 20, 2025 | SESE | | [K242495](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTR/K242495.md) | LMA Fastrach ETT SU | Teleflex Medical | Apr 29, 2025 | SESE | | [K241451](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTR/K241451.md) | Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric) | Teleflex Incorporated | Feb 11, 2025 | SESE | | [K233341](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTR/K233341.md) | Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410) | Covidien, LLC | May 20, 2024 | SESE | | [K223130](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTR/K223130.md) | Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160) | Covidien | Aug 30, 2023 | SESE | | [K211543](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTR/K211543.md) | Wei Nasal Jet Tube | Well Lead Medical Co., Ltd. | Jul 21, 2022 | SESE | | [K213028](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTR/K213028.md) | Tenax Laser Resistant Endotracheal Tube | Bryan Medical, Inc. | Oct 21, 2021 | SESE | | [K200761](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTR/K200761.md) | Tenax Laser Resistant Endotracheal Tube | Bryan Medical, Inc. | Nov 25, 2020 | SESE | | [K192120](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTR/K192120.md) | Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mm | Venner Medical (Singapore) Pte, Ltd. | Feb 14, 2020 | SESE | | [K190878](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTR/K190878.md) | Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff | Salter Labs, Inc. | Jan 10, 2020 | SESE | | [K182739](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTR/K182739.md) | Endotracheal Tube with Evacuation Lumen | Well Lead Medical Co., Ltd. | Dec 11, 2019 | SESE | | [K192324](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTR/K192324.md) | Sheridan Spiral-Flex Endotracheal Tubes | Teleflexmedical, Inc. | Dec 6, 2019 | SESE | | [K190630](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTR/K190630.md) | SolidAIRity III Airway Stabilization System | Securisyn Medical, LLC | Oct 9, 2019 | SESE | | [K190213](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTR/K190213.md) | Yikang Endotracheal Tube | Jiangxi Yikang Medical Instrument Group Co., Ltd. | Sep 6, 2019 | SESE | | [K190274](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTR/K190274.md) | Endotracheal Tube | Tianjin Medis Medical Device Co., Ltd. | Jul 30, 2019 | SESE | | [K181880](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTR/K181880.md) | VivaSight-SL (TVT) system | Etview , Ltd. | Nov 29, 2018 | SESE | ## Top Applicants - Sheridan Catheter Corp. — 11 clearances - Mallinckrodt Critical Care — 10 clearances - Rusch, Inc. — 10 clearances - Bivona Medical Technologies — 8 clearances - Polamedco, Inc. — 7 clearances --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTR](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTR) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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