K251950 is an FDA 510(k) clearance for the Endobronchial Blocker Tube (EBT0109). This device is classified as a Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) (Class II - Special Controls, product code CBI).
Submitted by Hangzhou Tappa Medical Technology Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on March 20, 2026, 268 days after receiving the submission on June 25, 2025.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5740.
| 510(k) Number | K251950 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 2025 |
| Decision Date | March 20, 2026 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CBI — Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5740 |