FDA product code QVO: Computerized Behavioral Therapy Device For Insomnia
QVO is the FDA product code for computerized behavioral therapy device for insomnia. It is a Class II device, regulated under 21 CFR 882.5801 and reviewed by the Neurology panel. FDA has cleared 2 510(k) submissions under QVO, 1 in the last five years, from 2 different applicants. The average 510(k) review took 272 days (median 272); 272 days on average over the last three years.
Definition
The device is intended to provide cognitive behavioral therapy to treat insomnia.
Classification
| Field | Value |
|---|---|
| Device name | Computerized Behavioral Therapy Device For Insomnia |
| Device class | Class II |
| Regulation | 21 CFR 882.5801 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for QVO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 271 |
| 2024 | 1 | 272 |
Compare with all 510(k) review times · Search every QVO clearance
Top QVO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Big Health, Inc. | 1 | 2024-08-05 |
| Pear Therapeutics, Inc. | 1 | 2020-03-23 |
Most recent QVO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233577 | Big Health, Inc. | Sleepio® | 2024-08-05 | 272 |
| K191716 | Pear Therapeutics, Inc. | Somryst | 2020-03-23 | 271 |
Recalls for QVO devices
openFDA lists no recalls for product code QVO.
Frequently asked questions
What is FDA product code QVO?
QVO is the FDA product code for computerized behavioral therapy device for insomnia. It is a Class II device, regulated under 21 CFR 882.5801 and reviewed by the Neurology panel.
What device class is QVO?
Class II, regulation 21 CFR 882.5801. Typical premarket route: 510(k).
How long does a 510(k) take for product code QVO?
Across 2 cleared submissions the average was 272 days from receipt to decision (median 272).
Which companies have the most QVO clearances?
Big Health, Inc. (1); Pear Therapeutics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QVO
- Run a recall and safety report across every QVO manufacturer
- Watch product code QVO 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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