BTR · Tube, Tracheal (W/Wo Connector)
Anesthesiology · 21 CFR 868.5730 · Class 2
Overview
| Product Code | BTR |
|---|---|
| Device Name | Tube, Tracheal (W/Wo Connector) |
| Regulation | 21 CFR 868.5730 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 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 | 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 | 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 | AeroJet Ventilation Catheter | Pipeline Medical Products, LLC | Aug 13, 2025 | SESE |
| K251499 | 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 | 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 | LMA Fastrach ETT SU | Teleflex Medical | Apr 29, 2025 | SESE |
| K241451 | Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric) | Teleflex Incorporated | Feb 11, 2025 | SESE |
| K233341 | 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 | 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 | Wei Nasal Jet Tube | Well Lead Medical Co., Ltd. | Jul 21, 2022 | SESE |
| K213028 | Tenax Laser Resistant Endotracheal Tube | Bryan Medical, Inc. | Oct 21, 2021 | SESE |
| K200761 | Tenax Laser Resistant Endotracheal Tube | Bryan Medical, Inc. | Nov 25, 2020 | SESE |
| K192120 | 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 | 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 | Endotracheal Tube with Evacuation Lumen | Well Lead Medical Co., Ltd. | Dec 11, 2019 | SESE |
| K192324 | Sheridan Spiral-Flex Endotracheal Tubes | Teleflexmedical, Inc. | Dec 6, 2019 | SESE |
| K190630 | SolidAIRity III Airway Stabilization System | Securisyn Medical, LLC | Oct 9, 2019 | SESE |
| K190213 | Yikang Endotracheal Tube | Jiangxi Yikang Medical Instrument Group Co., Ltd. | Sep 6, 2019 | SESE |
| K190274 | Endotracheal Tube | Tianjin Medis Medical Device Co., Ltd. | Jul 30, 2019 | SESE |
| K181880 | VivaSight-SL (TVT) system | Etview , Ltd. | Nov 29, 2018 | SESE |
Top Applicants
- Sheridan Catheter Corp. — 11 clearances
- Rusch, Inc. — 10 clearances
- Mallinckrodt Critical Care — 10 clearances
- Bivona Medical Technologies — 8 clearances
- Unomedical Sdn Bhd — 7 clearances
