Sleepiz AG

FDA Regulatory Profile

Sleepiz AG appears in FDA public data with 0 recalls, 3 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on January 28, 2026.

Summary

Total Recalls
0
510(k) Clearances
3
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K253388Sleepiz One+ (Model 2.5)January 28, 2026
K251364Sleepiz One+ (2.5)July 29, 2025
K223163Sleepiz One+August 18, 2023