Clearance Summary
Sleep Apnea Feature (v2.0) received FDA 510(k) clearance under submission number K261011, sponsored by Samsung Electronics Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2026-07-20.
- Submission: K261011
- Applicant / Sponsor: Samsung Electronics Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.2378
- Decision date: 2026-07-20
Classification & Regulation
This clearance is catalogued under FDA product code QZW and 21 CFR 868.2378, within the Anesthesiology review panel as a Class II device.