# DEN210015: Sunrise Sleep Disorder Diagnostic Aid

- Pathway: De Novo (Direct)
- Applicant: Sunrise
- Decided: Jan 7, 2022 after 280 days
- Product code: QRS (Device For Sleep Apnea Testing Based On Mandibular Movement)
- Device class: 2
- Regulation: 21 CFR 868.2376
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K222262: Sunrise (2022), 1 descendant of its own
- K250874: Sunrise (2025), 0 descendants of its own

## Indications for use
The Sunrise SDDA device is a non-invasive home care aid in the evaluation of obstructive sleep apnea (OSA) in patients 18 years and older with suspicions of sleep breathing disorders.

Source page: https://510kreport.com/device/DEN210015
Methodology: https://510kreport.com/methodology