# Sunrise SA

- Location (FDA's records): Namur, BE
- FDA decisions: 3 (2022–2025): 2 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Sunrise SA (2); Sunrise (1)
- Product codes: QRS (3)
- Predicates its devices cite: 2 (2 its own); citations of its devices by later devices: 2 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Its most-cited devices
- K222262: Sunrise (2022), cited by 1
- DEN210015: Sunrise Sleep Disorder Diagnostic Aid (2022), cited by 1

## Recent decisions
- K250874: Sunrise (Aug 29, 2025)
- K222262: Sunrise (Dec 22, 2022)
- DEN210015: Sunrise Sleep Disorder Diagnostic Aid (Jan 7, 2022)

Source page: https://510kreport.com/company/sunrise