BTR
- Product code
- BTR
- Device name
- Tube, Tracheal (W/Wo Connector)
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.5730
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- Flag
- Life-sustaining / life-supporting
- 510(k) clearances (last 3 years)
- 241
510(k) clearances, last 3 years (9)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253437 | 2026-06-12 | Spiro Robotics | Spiro-VISTA | |
| K250173 | 2025-10-06 | Covidien, LLC | Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye | |
| K243785 | 2025-09-25 | Covidien, LLC | Shiley Oral/Nasal Tracheal Tube with TaperGuard Cu | |
| K243579 | 2025-08-13 | Pipeline Medical Products, LLC | AeroJet Ventilation Catheter | |
| K251499 | 2025-06-11 | William Cook Europe Aps | Frova Intubating Introducer (C-CAE-14.0-70-FII); Fro | |
| K250243 | 2025-05-20 | Flexicare Medical Limited. | ProVu Single Use Video Stylet with Reinforced ET Tub | |
| K242495 | 2025-04-29 | Teleflex Medical | LMA Fastrach ETT SU | |
| K241451 | 2025-02-11 | Teleflex Incorporated | Rusch Endotracheal Tubes (Reinforced); Rusch Endotra | |
| K233341 | 2024-05-20 | Covidien, LLC | Shiley Oral/Nasal Endotracheal Tube Intermediate Cu |
Official FDA classification page: BTR
Classification and pathway per current FDA publications. Data from openFDA (CC0).