# K240929: Sleep Apnea Notification Feature (SANF)

- Pathway: 510(k) (Traditional)
- Applicant: Apple, Inc.
- Decided: Sep 13, 2024 after 162 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
Longest line of descent: 1 generation back to DEN230041 (2024). 1 ancestor in all.
1 later device descends from it; 1 cites 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)
- DEN230041: Sleep Apnea Feature, Samsung Electronics Co., Ltd. (2024) Summary page 5.

## Most influential descendants
- K261011: Sleep Apnea Feature (v2.0) (2026), 0 descendants of its own

## Indications for use
The Sleep Apnea Notification Feature (SANF) is a software-only mobile medical application that analyzes Apple Watch sensor data to identify patterns of breathing disturbances suggestive of moderate-to-severe sleep apnea and provides a notification to the user. This feature is intended for over-the-counter (OTC) use by adults age 18 and over who have not previously received a sleep apnea diagnosis and is not intended to diagnose, treat, or aid in the management of sleep apnea. The absence of a notification is not intended to indicate the absence of sleep apnea.

Source page: https://510kreport.com/device/K240929
Methodology: https://510kreport.com/methodology