BTO
- Product code
- BTO
- Device name
- Tube, Tracheostomy (W/Wo Connector)
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.5800
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- Flag
- Life-sustaining / life-supporting
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 128
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K242921 | 2025-06-10 | Vitaltec Corporation | 5300600-5301000 Rota-Trach Disposable Standard Trach | FDA |
| K233713 | 2024-03-22 | Teleflex Medical | Pilling Tracheostomy Tubes |
Official FDA classification page: BTO
Classification and pathway per current FDA publications. Data from openFDA (CC0).