BTR — Tube, Tracheal (W/Wo Connector) Class II
FDA Device Classification
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 |
|---|
| 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 |
| K181880 | etview | VivaSight-SL (TVT) system | November 29, 2018 |