FDA product code QAV: High Flow/High Velocity Humidified Oxygen Delivery Device
QAV is the FDA product code for high flow/high velocity humidified oxygen delivery device. It is a Class II device, regulated under 21 CFR 868.5454 and reviewed by the Anesthesiology panel. FDA has cleared 2 510(k) submissions under QAV, 2 in the last five years, from 2 different applicants. The average 510(k) review took 242 days (median 242). 1 De Novo request was granted under it. FDA has posted 1 recall for QAV devices, 1 initiated in the last five years.
Definition
Intended to deliver high flow and/or high velocity oxygen with humidification.
Classification
| Field | Value |
|---|---|
| Device name | High Flow/High Velocity Humidified Oxygen Delivery Device |
| Device class | Class II |
| Regulation | 21 CFR 868.5454 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
510(k) clearances per year for QAV
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 221 |
| 2023 | 1 | 263 |
Compare with all 510(k) review times · Search every QAV clearance
Top QAV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fisher & Paykel Healthcare | 1 | 2023-01-27 |
| Vapotherm, Inc. | 1 | 2022-12-13 |
Most recent QAV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K221338 | Fisher & Paykel Healthcare | F&P Airvo 3 | 2023-01-27 | 263 |
| K221318 | Vapotherm, Inc. | HVT 2.0 | 2022-12-13 | 221 |
Recalls for QAV devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-08-07.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code QAV?
QAV is the FDA product code for high flow/high velocity humidified oxygen delivery device. It is a Class II device, regulated under 21 CFR 868.5454 and reviewed by the Anesthesiology panel.
What device class is QAV?
Class II, regulation 21 CFR 868.5454. Typical premarket route: 510(k).
How long does a 510(k) take for product code QAV?
Across 2 cleared submissions the average was 242 days from receipt to decision (median 242).
Which companies have the most QAV clearances?
Fisher & Paykel Healthcare (1); Vapotherm, Inc. (1).
Have QAV devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2024-08-07.
Next steps
- Run an FDA pathway report with predicate devices for product code QAV
- Run a recall and safety report across every QAV manufacturer
- Watch product code QAV for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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