FDA product code QZW: Over-The-Counter Device To Assess Risk Of Sleep Apnea
QZW is the FDA product code for over-the-counter device to assess risk of sleep apnea. It is a Class II device, regulated under 21 CFR 868.2378 and reviewed by the Anesthesiology panel. FDA has cleared 2 510(k) submissions under QZW, 2 in the last five years, from 2 different applicants. The average 510(k) review took 139 days (median 139); 139 days on average over the last three years. 1 De Novo request was granted under it.
Definition
An over-the-counter device to assess risk of sleep apnea is intended to provide a notification of the risk of sleep apnea in users who have not been previously diagnosed with sleep apnea. This device uses software algorithms to analyze input sensor signals and provide a risk assessment for sleep apnea. It is not intended to provide a standalone diagnosis, replace traditional methods of diagnosis (e.g., polysomnography), assist clinicians in diagnosing sleep disorders, or be used as an apnea monitor.
Classification
| Field | Value |
|---|---|
| Device name | Over-The-Counter Device To Assess Risk Of Sleep Apnea |
| Device class | Class II |
| Regulation | 21 CFR 868.2378 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
510(k) clearances per year for QZW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 162 |
| 2026 | 1 | 116 |
Compare with all 510(k) review times · Search every QZW clearance
Top QZW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Samsung Electronics Co., Ltd. | 1 | 2026-07-20 |
| Apple, Inc. | 1 | 2024-09-13 |
Most recent QZW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261011 | Samsung Electronics Co., Ltd. | Sleep Apnea Feature (v2.0) | 2026-07-20 | 116 |
| K240929 | Apple, Inc. | Sleep Apnea Notification Feature (SANF) | 2024-09-13 | 162 |
Recalls for QZW devices
openFDA lists no recalls for product code QZW.
Frequently asked questions
What is FDA product code QZW?
QZW is the FDA product code for over-the-counter device to assess risk of sleep apnea. It is a Class II device, regulated under 21 CFR 868.2378 and reviewed by the Anesthesiology panel.
What device class is QZW?
Class II, regulation 21 CFR 868.2378. Typical premarket route: 510(k).
How long does a 510(k) take for product code QZW?
Across 2 cleared submissions the average was 139 days from receipt to decision (median 139).
Which companies have the most QZW clearances?
Samsung Electronics Co., Ltd. (1); Apple, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QZW
- Run a recall and safety report across every QZW manufacturer
- Watch product code QZW 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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