Sleep Apnea Feature (v2.0)
FDA 510(k) clearance K261011 · decided 2026-07-20
Clearance details
- K-number
- K261011
- Device name
- Sleep Apnea Feature (v2.0)
- Applicant
- Samsung Electronics Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2026-03-26
- Decision date
- 2026-07-20
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- QZW
- Device class
- 2
- Regulation number
- 868.2378
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Suwon-Si, KR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Sleep Apnea Notification Feature (SANF) (K240929) | Apple, Inc. | 2024-09-13 |
| Sleep Apnea Feature (DEN230041) | Samsung Electronics Co., Ltd. | 2024-02-06 |
Recalls involving this device
No recalls on record reference this clearance.