# K222262: Sunrise

- Pathway: 510(k) (Traditional)
- Applicant: Sunrise SA
- Decided: Dec 22, 2022 after 147 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
Longest line of descent: 1 generation back to DEN210015 (2022). 1 ancestor in all.
1 later device descends 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)
- DEN210015: Sunrise Sleep Disorder Diagnostic Aid, Sunrise (2022) Summary page 4.

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

## Indications for use
The Sunrise 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/K222262
Methodology: https://510kreport.com/methodology