Cleared Special

Sleepiz One+ (2.5)

K251364 · Sleepiz AG · Cardiovascular

Jul 2025

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K251364 is an FDA 510(k) clearance for the Sleepiz One+ (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 July 29, 2025, 89 days after receiving the submission on May 1, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K251364 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 01, 2025
Decision Date	July 29, 2025
Days to Decision	89 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF