FDA 510(k) · Samsung
K261011: Sleep Apnea Feature (v2.0) (Samsung Electronics Co., Ltd.)
Samsung Electronics Co., Ltd. received FDA 510(k) K261011 for Sleep Apnea Feature (v2.0), with a decision date of Jul 20, 2026 (substantially equivalent).
Prescription or OTC: OTC parsed from FDA documents (summary PDF: indications text (parsed))
FDA facts
| FDA number | K261011 |
|---|---|
| Pathway | 510(k) |
| Applicant | Samsung Electronics Co., Ltd. |
| Device name | Sleep Apnea Feature (v2.0) |
| Product code | QZW: Over-The-Counter Device To Assess Risk Of Sleep Apnea |
| Regulation (21 CFR) | 868.2378 |
| Device class | Class 2 |
| Date received | Mar 26, 2026 |
| Decision date | Jul 20, 2026 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
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.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code QZW is "Over-The-Counter Device To Assess Risk Of Sleep Apnea", class 2, 21 CFR 868.2378. FDA's definition: "An over-the-counter device to assess risk of sleep apnea is intended to provide a notification of the risk of sleep apnea in users who have not been previously diagnosed with sleep apnea. This device uses software algorithms to analyze input sensor signals and provide a risk assessment for sleep apnea. It is not intended to provide a standalone diagnosis, replace traditional methods of diagnosis (e.g., polysomnography), assist clinicians in diagnosing sleep disorders, or be used as an apnea monitor."
Our labels for filtering: claim Sleep apnea, sensor Unknown. These are heuristics, not FDA fields.