Sunrise
FDA 510(k) clearance K222262 · decided 2022-12-22
Clearance details
- K-number
- K222262
- Device name
- Sunrise
- Applicant
- Sunrise SA
- Decision
- Substantially Equivalent
- Date received
- 2022-07-28
- Decision date
- 2022-12-22
- Days to decision
- 147 days
- Clearance type
- Traditional
- Product code
- QRS
- Device class
- 2
- Regulation number
- 868.2376
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Namur, BE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Sunrise (K250874) | Sunrise SA | 2025-08-29 |
| Sunrise Sleep Disorder Diagnostic Aid (DEN210015) | Sunrise | 2022-01-07 |
Recalls involving this device
No recalls on record reference this clearance.