# Sleepiz AG

- Location (FDA's records): Zurich, CH
- FDA decisions: 3 (2023–2026): 3 510(k) clearances
- Product codes: DRT (3)
- Predicates its devices cite: 3 (2 its own); citations of its devices by later devices: 3 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Xandar Kardian, Inc.: 1 (https://510kreport.com/company/xandar-kardian)

## Firms that cite its devices most
- Life Detection Technologies: 1 (https://510kreport.com/company/life-detection-technologies)

## Its most-cited devices
- K223163: Sleepiz One+ (2023), cited by 2
- K251364: Sleepiz One+ (2.5) (2025), cited by 1

## Recent decisions
- K253388: Sleepiz One+ (Model 2.5) (Jan 28, 2026)
- K251364: Sleepiz One+ (2.5) (Jul 29, 2025)
- K223163: Sleepiz One+ (Aug 18, 2023)

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