BSK
- Product code
- BSK
- Device name
- Cuff, Tracheal Tube, Inflatable
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.5750
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- Flag
- Life-sustaining / life-supporting
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 40
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261499 | 2026-08-13 | Aw Technologies Aps | TrachFlush | |
| K243562 | 2025-08-12 | Idmed | CuffGuard | FDA |
| K242642 | 2025-03-07 | Shanghai Longmann Tech Co., Ltd. | CuffTrek |
Official FDA classification page: BSK
Classification and pathway per current FDA publications. Data from openFDA (CC0).