510(k) · Cleared
ClearedSleep Apnea Notification Feature (SANF)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apple, Inc. · QZW Over-The-Counter Device To Assess Risk Of Sleep Apnea
Cleared on Sep 13, 2024 as substantially equivalent to DEN230041 (Samsung Electronics Co., Ltd., 2024) after a 162-day review. Its family tree reaches back 1 generation to 2024. 1 later device descends from it.
- Decided
- Sep 13, 2024
- Review
- 162 days
- Class
- Class II
- Product code
- QZW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN230041 (2024). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K261011Sleep Apnea Feature (v2.0)Samsung Electronics Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN230041 | Sleep Apnea Feature | Samsung Electronics Co., Ltd. | 2024 | — |
| 0 (this device) | K240929 | Sleep Apnea Notification Feature (SANF) | Apple, Inc. | 2024 | — |
| +1 | K261011 | Sleep Apnea Feature (v2.0) | Samsung Electronics Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QZW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QZW device
- #1 K261011 Sleep Apnea Feature (v2.0)score 12.0 · 2 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN230041 | Sleep Apnea FeatureSummary page 5…Anesthesiology 3. Predicate Device Predicate Manufacturer Samsung Electronics Co., Ltd Predicate Trade Name Sleep Apnea Feature Predicate 510(k) DEN230041 One Apple Park Way Cupertino, CA 95014 Page 1 of 9 Apple In… | 2024 |
| † | K192469 | Nox Sleep System | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261011 | Sleep Apnea Feature (v2.0) | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All QZW devicesQZW Over-The-Counter Device To Assess Risk Of Sleep Apnea: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QZW
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QZW
Too few QZW 510(k)s in any year since 2007 to give a median.
Recalls per year · QZW
No recall names QZW since 2007.
Adverse event reports per year · QZW
2in 2025
MAUDE reports naming product code QZW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240929 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240929: Sleep Apnea Notification Feature (SANF).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240929
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026