510(k) · Cleared
ClearedSleep Apnea Feature (v2.0)
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
Cleared on Jul 20, 2026 as substantially equivalent to DEN230041 (Samsung Electronics Co., Ltd., 2024) and 1 other predicate after a 116-day review. Its family tree reaches back 2 generations to 2024.
- Decided
- Jul 20, 2026
- Review
- 116 days
- Class
- Class II
- Product code
- QZW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to DEN230041 (2024). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 K240929 Sleep Apnea Notification Feature (SANF)score 11.0 · 1 generation · no Class I recall
What was it cleared against? (2)
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… QZW - Over-the-counter device to assess risk of sleep apnea (21 CFR 868.2378) Predicate Device: Sleep Apnea Feature (DEN230041) Reference Device Sleep Apnea Notification Feature (SANF) (K240929) Device Description The Samsung Sleep Apnea… | 2024 |
| * | K240929 | Sleep Apnea Notification Feature (SANF)Summary page 5…CFR 868.2378) Predicate Device: Sleep Apnea Feature (DEN230041) Reference Device Sleep Apnea Notification Feature (SANF) (K240929) Device Description The Samsung Sleep Apnea Feature v2.0 is a Software as a Medical Device (SaMD) application, requiring a pa… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 2 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate DEN230041.
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. 2026, 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 Wearable and Phone.
This feature is intended to detect signs of moderate to severe sleep apnea in the form of significant breathing disruptions in users 18 years and older, over a two-night monitoring period. It is intended for on-demand use and requires two nights of valid data within a 10-day period.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261011 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261011: Sleep Apnea Feature (v2.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261011
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026