Other
Sleep Apnea Notification Feature (SANF)
Apple Inc.
FDA
FDA-cleared AI medical device
Over-the-counter software feature that analyzes accelerometer-derived measures of breathing disturbance during sleep, collected across nights within a 30-day window, to notify users aged 18 and over without a prior diagnosis when the pattern is consistent with moderate-to-severe obstructive sleep apnea.
FDA Submission Metadata
- Submission number
- K240929
- Decision date
- September 2024
- FDA panel
- Anesthesiology
- Product code
- QZW
- Clinical task (npj)
- diagnosis
- Data modality (npj)
- Signals
This entry's identity, manufacturer, and clearance have been verified against primary regulatory sources. A full editorial deep-dive — performance, clinical evidence, and safety record — may follow.
Regulatory Approvals
FDA