# DEN230041: Sleep Apnea Feature

- Pathway: De Novo (Direct)
- Applicant: Samsung Electronics Co., Ltd.
- Decided: Feb 6, 2024 after 251 days
- Product code: QZW (Over-The-Counter Device To Assess Risk Of Sleep Apnea)
- Device class: 2
- Regulation: 21 CFR 868.2378
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K240929: Sleep Apnea Notification Feature (SANF) (2024), 1 descendant of its own
- K261011: Sleep Apnea Feature (v2.0) (2026), 0 descendants of its own

## Indications for use
The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone. This feature 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 is intended for on demand use. This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this device is also not intended to assist clinicians in diagnosing sleep disorders.

Source page: https://510kreport.com/device/DEN230041
Methodology: https://510kreport.com/methodology