Cleared Traditional

K223163 - Sleepiz One+ (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K223163 · Sleepiz AG · Cardiovascular device
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Aug 2023
Decision
315d
Days
Class 2
Risk

K223163 is an FDA 510(k) clearance for the Sleepiz One+. 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 August 18, 2023 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Sleepiz AG devices

Submission Details

510(k) Number K223163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2022
Decision Date August 18, 2023
Days to Decision 315 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
190d slower than avg
Panel avg: 125d · This submission: 315d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
Prithul Bom

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K223163.
The Circadia C300 System (C300)
K252676 · Circadia Health, Inc. · Feb 2026
Sleepiz One+ (Model 2.5)
K253388 · Sleepiz AG · Jan 2026
Sleepiz One+ (2.5)
K251364 · Sleepiz AG · Jul 2025
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