Sleepiz One+ (Model 2.5)— 510(k) K253388

Substantially Equivalent

Sleepiz AG

FDA 510(k) clearance K253388 for Sleepiz One+ (Model 2.5), Substantially Equivalent on 2026-01-28. Applicant: Sleepiz AG.

Clearance details

Applicant: Sleepiz AG
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 2025-09-30
Decision date: 2026-01-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Zurich, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.