FDA De Novo · Samsung
DEN230041: Sleep Apnea Feature (Samsung Electronics Co., Ltd.)
Samsung Electronics Co., Ltd. received FDA De Novo DEN230041 for Sleep Apnea Feature, with a decision date of Feb 6, 2024.
Prescription or OTC: OTC parsed from FDA documents (summary PDF: indications text (parsed))
FDA facts
| FDA number | DEN230041 |
|---|---|
| Pathway | De Novo |
| Applicant | Samsung Electronics Co., Ltd. |
| Device name | Sleep Apnea Feature |
| Product code | QZW: Over-The-Counter Device To Assess Risk Of Sleep Apnea |
| Regulation (21 CFR) | 868.2378 |
| Device class | Class 2 |
| Date received | May 31, 2023 |
| Decision date | Feb 6, 2024 |
| Decision | Unknown (DENG) |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The Sleep Apnea Feature is indicated as follows: 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.
Extracted automatically from FDA's decision 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
A De Novo request is for a new type of device with no legally marketed predicate. When FDA grants it, the device can serve as a predicate for later 510(k) submissions. 2 records in this database cite DEN230041 as a predicate (listed below).
Later records that cite DEN230041
ChatPPG interpretation
A granted De Novo request authorizes a new type of low- to moderate-risk device and creates a classification regulation for it (here 21 CFR 868.2378). The usual wording is "granted" or "authorized", not "approved". 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.