# K250874: Sunrise

- Pathway: 510(k) (Traditional)
- Applicant: Sunrise SA
- Decided: Aug 29, 2025 after 158 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: 2 generations back to DEN210015 (2022). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222262: Sunrise, Sunrise SA (2022) Summary page 5.

## Indications for use
The Sunrise Air 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/K250874
Methodology: https://510kreport.com/methodology