HVT 2.0
FDA 510(k) K221318 · Vapotherm, Inc.
510(k) numberK221318
Submission
- Device name
- HVT 2.0
- Applicant
- Vapotherm, Inc.
Exeter, NH, US - Received
- May 6, 2022
- Decision date
- December 13, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QAV – High Flow/High Velocity Humidified Oxygen Delivery Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5454
- Specialty
- Anesthesiology
Intended to deliver high flow and/or high velocity oxygen with humidification.
Other 510(k)s with product code QAV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K221338 | F&P Airvo 3QAV · Traditional | Fisher & Paykel Healthcare | 01/27/2023SE |
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| K070056 | Vapotherm Model# 2000I and 2000HBTT · Special | 04/13/2007SE |
| K042245 | Vapotherm MODEL#2000I, 200HBTT · Traditional | 08/30/2004SE |
| K013486 | Vapotherm 2000HBTT · Traditional | 05/30/2003SE |
Questions and answers
When was HVT 2.0 cleared by the FDA?
HVT 2.0 (K221318) received a 510(k) decision of Substantially Equivalent on December 13, 2022, 221 days after the submission was received.
What is the product code of K221318?
The FDA product code is QAV – High Flow/High Velocity Humidified Oxygen Delivery Device, a Class II (moderate risk) device regulated under 21 CFR 868.5454.