FDA 510(k) · Apple
K240929: Sleep Apnea Notification Feature (SANF) (Apple, Inc.)
Apple, Inc. received FDA 510(k) K240929 for Sleep Apnea Notification Feature (SANF), with a decision date of Sep 13, 2024 (substantially equivalent).
Prescription or OTC: OTC parsed from FDA documents (summary PDF: Form 3881 Type of Use (parsed))
FDA facts
| FDA number | K240929 |
|---|---|
| Pathway | 510(k) |
| Applicant | Apple, Inc. |
| Device name | Sleep Apnea Notification Feature (SANF) |
| Product code | QZW: Over-The-Counter Device To Assess Risk Of Sleep Apnea |
| Regulation (21 CFR) | 868.2378 |
| Device class | Class 2 |
| Date received | Apr 4, 2024 |
| Decision date | Sep 13, 2024 |
| 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 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.
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.
- DEN230041 Sleep Apnea Feature (Samsung)
Later records that cite K240929
- K261011 Sleep Apnea Feature (v2.0) (Samsung, Jul 20, 2026, QZW)
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.