> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Apple Watch Cleared for Assessing Sleep Apnea
- URL: https://www.fdaweb.com/apple-watch-cleared-for-assessing-sleep-apnea/
- Published: 2024-09-16T12:00:00.000Z
- Updated: 2026-09-14T14:41:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157781

FDA has cleared an Apple 510(k) for its Apple Watch to be used as an over-the-counter device for assessing the risk of sleep apnea. The device is intended to provide a notification of the risk of sleep apnea in users who have not been previously diagnosed with sleep apnea, according to an [agency notice](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=213&ref=fdaweb.com) about the clearance. “This device uses software algorithms to analyze input sensor signals and provide a risk assessment for sleep apnea,” it says, adding that 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.