510(k) K250874
K250874 is an FDA 510(k) premarket notification submitted by Sunrise SA for the device "Sunrise". The FDA issued a decision of Substantially Equivalent on August 29, 2025. The device falls under product code QRS (Device For Sleep Apnea Testing Based On Mandibular Movement), a Class II device regulated under 21 CFR 868.2376. Sunrise SA has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 29, 2025
- Date Received
- March 24, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device For Sleep Apnea Testing Based On Mandibular Movement
- Device Class
- Class II
- Regulation Number
- 868.2376
- Review Panel
- AN
- Submission Type
A device for sleep apnea testing based on mandibular movement is a prescription device intended to aid in evaluation of sleep apnea during sleep in patients suspected of having sleep breathing disorders by analyzing sensor readings of mandibular movement. The device is not intended as a substitute for full polysomnography nor intended to be used as an apnea monitor.