K242642 is an FDA 510(k) clearance for the CuffTrek. This device is classified as a Cuff, Tracheal Tube, Inflatable (Class II - Special Controls, product code BSK).
Submitted by Shanghai Longmann Tech Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on March 7, 2025, 185 days after receiving the submission on September 3, 2024.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5750.
| 510(k) Number | K242642 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2024 |
| Decision Date | March 07, 2025 |
| Days to Decision | 185 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BSK - Cuff, Tracheal Tube, Inflatable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5750 |