K251133 is an FDA 510(k) clearance for the AVEA disposable expiratory filter/water trap (11790). This device is classified as a Ventilator, Continuous, Facility Use (Class II - Special Controls, product code CBK).
Submitted by Telesair, Inc. (Irvine, US). The FDA issued a Cleared decision on May 8, 2025, 27 days after receiving the submission on April 11, 2025.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K251133 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 2025 |
| Decision Date | May 08, 2025 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CBK - Ventilator, Continuous, Facility Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5895 |