K250874 is an FDA 510(k) clearance for the Sunrise. This device is classified as a Device For Sleep Apnea Testing Based On Mandibular Movement (Class II - Special Controls, product code QRS).
Submitted by Sunrise SA (Namur, BE). The FDA issued a Cleared decision on August 29, 2025, 158 days after receiving the submission on March 24, 2025.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2376. 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..
| 510(k) Number | K250874 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 2025 |
| Decision Date | August 29, 2025 |
| Days to Decision | 158 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | QRS - Device For Sleep Apnea Testing Based On Mandibular Movement |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2376 |
| Definition | 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. |