K221318 is an FDA 510(k) clearance for the HVT 2.0. This device is classified as a High Flow/high Velocity Humidified Oxygen Delivery Device (Class II - Special Controls, product code QAV).
Submitted by Vapotherm, Inc. (Exeter, US). The FDA issued a Cleared decision on December 13, 2022, 221 days after receiving the submission on May 6, 2022.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5454. Intended To Deliver High Flow And/or High Velocity Oxygen With Humidification..
| 510(k) Number | K221318 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 2022 |
| Decision Date | December 13, 2022 |
| Days to Decision | 221 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | QAV - High Flow/high Velocity Humidified Oxygen Delivery Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5454 |
| Definition | Intended To Deliver High Flow And/or High Velocity Oxygen With Humidification. |