510(k) K261011
K261011 is an FDA 510(k) premarket notification submitted by Samsung Electronics Co., Ltd. for the device "Sleep Apnea Feature (v2.0)". The FDA issued a decision of Substantially Equivalent on July 20, 2026. The device falls under product code QZW (Over-The-Counter Device To Assess Risk Of Sleep Apnea), a Class II device regulated under 21 CFR 868.2378. Samsung Electronics Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 20, 2026
- Date Received
- March 26, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Over-The-Counter Device To Assess Risk Of Sleep Apnea
- Device Class
- Class II
- Regulation Number
- 868.2378
- Review Panel
- AN
- Submission Type
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.