Sleep Apnea Feature (v2.0)
Device Facts
| Record ID | K261011 |
|---|---|
| Device Name | Sleep Apnea Feature (v2.0) |
| Applicant | Samsung Electronics Co., Ltd. |
| Product Code | QZW · Anesthesiology |
| Decision Date | Jul 20, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.2378 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone. It is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a two-night monitoring period. It uses software algorithms to analyze input sensor signals (PPG and actigraphy) to 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.
Special Controls
In combination with the general controls of the FD&C Act, the over-the-counter device to assess risk of sleep apnea is subject to the following special controls:
