Cleared Special

K251364 - Sleepiz One+ (2.5) (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K251364 · Sleepiz AG · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
89d
Days
Class 2
Risk

K251364 is an FDA 510(k) clearance for the Sleepiz One+ (2.5). Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Sleepiz AG (Zurich, CH). The FDA issued a Cleared decision on July 29, 2025 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sleepiz AG devices

Submission Details

510(k) Number K251364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 125d · This submission: 89d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 337
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K251364.
The Circadia C300 System (C300)
K252676 · Circadia Health, Inc. · Feb 2026
Sleepiz One+ (Model 2.5)
K253388 · Sleepiz AG · Jan 2026
The Circadia C200 System
K234003 · Circadia Technologies, Ltd. · May 2024
Vios Monitoring System(TM) Model 2050
K232354 · Murata Vios, Inc. · Mar 2024
Neteera 130H-Plus Vital Sign Monitoring Sensor
K231733 · Neteera Technologies , Ltd. · Feb 2024
Sleepiz One+
K223163 · Sleepiz AG · Aug 2023