BTR — Tube, Tracheal (W/Wo Connector) Class II
FDA product code BTR covers "Tube, Tracheal (W/Wo Connector)", a Class II medical device regulated under 21 CFR 868.5730. 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
- BTR
- Device Class
- Class II
- Regulation Number
- 868.5730
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251794 | Bryan Medical | Tenax® Laser Resistant Endotracheal Tube | Sep 3, 2026 |
| K253437 | Spiro Robotics | Spiro-VISTA | Jun 12, 2026 |
| K250173 | Covidien | Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE T | Oct 6, 2025 |
| K243785 | Covidien | Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye S | Sep 25, 2025 |
| K243579 | Pipeline Medical Products | AeroJet Ventilation Catheter | Aug 13, 2025 |
| K251499 | William Cook Europe Aps | Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C- | Jun 11, 2025 |
| K250243 | Flexicare Medical Limited | ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); | May 20, 2025 |
| K242495 | Teleflex Medical | LMA Fastrach ETT SU | Apr 29, 2025 |
| K241451 | Teleflex Incorporated | Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); | Feb 11, 2025 |
| K233341 | Covidien | Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, | May 20, 2024 |
| K223130 | Covidien | Shiley Pediatric Oral/Nasal Endotracheal Tube with TaperGuard Cuff, Non DEHP ( | Aug 30, 2023 |
| K211543 | Well Lead Medical Co | Wei Nasal Jet Tube | Jul 21, 2022 |
| K213028 | Bryan Medical | Tenax Laser Resistant Endotracheal Tube | Oct 21, 2021 |
| K200761 | Bryan Medical | Tenax Laser Resistant Endotracheal Tube | Nov 25, 2020 |
| K192120 | Venner Medical (Singapore) Pte | Venner PneuX ETT (Endotracheal Tube) 6 mm, Venner PneuX ETT (Endotracheal Tu | Feb 14, 2020 |
| K190878 | Salter Labs | Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-T | Jan 10, 2020 |
| K182739 | Well Lead Medical Co | Endotracheal Tube with Evacuation Lumen | Dec 11, 2019 |
| K192324 | Teleflexmedical | Sheridan Spiral-Flex Endotracheal Tubes | Dec 6, 2019 |
| K190630 | Securisyn Medical | SolidAIRity III Airway Stabilization System | Oct 9, 2019 |
| K190213 | Jiangxi Yikang Medical Instrument Group Co | Yikang Endotracheal Tube | Sep 6, 2019 |