Cleared Special

Sleepiz One+ (Model 2.5)

K253388 · Sleepiz AG · Cardiovascular

Jan 2026

Decision

120d

Days

Class 2

Risk

About This 510(k) Submission

K253388 is an FDA 510(k) clearance for the Sleepiz One+ (Model 2.5), a Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (Class II — Special Controls, product code DRT), submitted by Sleepiz AG (Zurich, CH). The FDA issued a Cleared decision on January 28, 2026, 120 days after receiving the submission on September 30, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K253388 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2025
Decision Date	January 28, 2026
Days to Decision	120 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF