Cleared Traditional

Onera Sleep Test System (Onera STS) (K223573) - FDA 510(k) Clearance

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

K223573 · Onera B.V. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
261d
Days
Class 2
Risk

K223573 is an FDA 510(k) clearance for the Onera Sleep Test System (Onera STS). Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Onera B.V. (Eindhoven, NL). The FDA issued a Cleared decision on August 18, 2023 after a review of 261 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 868.2375 - the FDA neurology device 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Onera B.V. devices

Submission Details

510(k) Number K223573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2022
Decision Date August 18, 2023
Days to Decision 261 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 148d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MNR Ventilatory Effort Recorder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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 Neurology devices follow this clearance model.

Regulatory Peers - MNR Ventilatory Effort Recorder

All 53
Devices cleared under the same product code (MNR) and FDA review panel - the closest regulatory comparables to K223573.
SAM Model 9-10000
K240100 · Snap Diagnostics, LLC · Jun 2024
Aurora
K231355 · Ensodata · Feb 2024
Somfit
K231546 · Compumedics Limited · Nov 2023
Wesper Lab
K221816 · Wesper, Inc. · Mar 2023
Belun Sleep System BLS-100
K222579 · Belun Technology Company Limited · Feb 2023
AcuPebble OX100
K222950 · Acurable Limited · Feb 2023