Sunrise Sleep Disorder Diagnostic Aid
FDA 510(k) clearance DEN210015 · decided 2022-01-07
Clearance details
- K-number
- DEN210015
- Device name
- Sunrise Sleep Disorder Diagnostic Aid
- Applicant
- Sunrise
- Decision
- Unknown
- Date received
- 2021-04-02
- Decision date
- 2022-01-07
- Days to decision
- 280 days
- Clearance type
- Direct
- 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
+ Add to Predicate Builder ◉ Watch Sunrise
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 (K222262) | Sunrise SA | 2022-12-22 |
Recalls involving this device
No recalls on record reference this clearance.