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 |
|---|---|---|---|
| K253437 | spiro robotics | Spiro-VISTA | June 12, 2026 |
| K250173 | covidien | Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE T | October 6, 2025 |
| K243785 | covidien | Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye S | September 25, 2025 |
| K243579 | pipeline medical products | AeroJet Ventilation Catheter | August 13, 2025 |
| K251499 | william cook europe aps | Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C- | June 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 | April 29, 2025 |
| K241451 | teleflex incorporated | Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); | February 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 ( | August 30, 2023 |
| K211543 | well lead medical co | Wei Nasal Jet Tube | July 21, 2022 |
| K213028 | bryan medical | Tenax Laser Resistant Endotracheal Tube | October 21, 2021 |
| K200761 | bryan medical | Tenax Laser Resistant Endotracheal Tube | November 25, 2020 |
| K192120 | venner medical (singapore) pte | Venner PneuX ETT (Endotracheal Tube) 6 mm, Venner PneuX ETT (Endotracheal Tu | February 14, 2020 |
| K190878 | salter labs | Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-T | January 10, 2020 |
| K182739 | well lead medical co | Endotracheal Tube with Evacuation Lumen | December 11, 2019 |
| K192324 | teleflexmedical | Sheridan Spiral-Flex Endotracheal Tubes | December 6, 2019 |
| K190630 | securisyn medical | SolidAIRity III Airway Stabilization System | October 9, 2019 |
| K190213 | jiangxi yikang medical instrument group co | Yikang Endotracheal Tube | September 6, 2019 |
| K190274 | tianjin medis medical device co | Endotracheal Tube | July 30, 2019 |