De Novo · Granted
GrantedSleep Apnea Feature
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Samsung Electronics Co., Ltd. · QZW Over-The-Counter Device To Assess Risk Of Sleep Apnea
Granted on Feb 6, 2024 as a new device type through De Novo after a 251-day review. 2 later devices descend from it.
- Decided
- Feb 6, 2024
- Review
- 251 days
- Class
- Class II
- Product code
- QZW
- Recalls
- None
2 later devices descend from it, 2 citing it directly.
- This deviceDEN230041 Sleep Apnea FeatureSamsung Electronics Co., Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK240929 Sleep Apnea Notification Feature (SANF)Apple, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK261011 Sleep Apnea Feature (v2.0)Samsung Electronics Co., Ltd. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN230041 | Sleep Apnea Feature | Samsung Electronics Co., Ltd. | 2024 | — |
| +1 | 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 |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA De Novo 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
- #2 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K240929 (Apple, Inc., 2024) has gone furthest, with 1 descendant of its own.
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 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…
Read the full statement (111 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN230041 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN230041: Sleep Apnea Feature.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN230041
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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