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

Name: FDA 510(k) clearance K253388
Creator: U.S. Food and Drug Administration
Published: 2026-01-28

Substantially Equivalent

Sleepiz AG

FDA 510(k) clearance K253388 for Sleepiz One+ (Model 2.5), Substantially Equivalent on 2026-01-28. Applicant: Sleepiz AG. Device class: 2.

Clearance details

Applicant: Sleepiz AG
Product code: Code DRT
Device class: Class 2
Regulation: 21 CFR 870.2300
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 ↗

Recent devices under product code DRT

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K261286 — The Circadia C300 System (C300)2026-05-20
K252676 — The Circadia C300 System (C300)2026-02-03
K251364 — Sleepiz One+ (2.5)2025-07-29
K234003 — The Circadia C200 System2024-05-30
K232354 — Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software2024-03-22

More clearances from Sleepiz AG

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K223163 — Sleepiz One+2023-08-18

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.