Cleared Traditional

K243220 - Onera STS 2 (ONERA STS 2) (FDA 510(k) Clearance)

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

K243220 · Onera B.V. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
269d
Days
Class 2
Risk

K243220 is an FDA 510(k) clearance for the Onera STS 2 (ONERA STS 2). 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 July 3, 2025 after a review of 269 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 K243220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2024
Decision Date July 03, 2025
Days to Decision 269 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d slower than avg
Panel avg: 148d · This submission: 269d
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 160
Devices cleared under the same product code (MNR) and FDA review panel - the closest regulatory comparables to K243220.
CASSIE
K252628 · Wesper, Inc. · Apr 2026
SANSA HSAT
K252497 · Huxley Medical · Dec 2025
SANSA HSAT
K250882 · Huxley Medical · Oct 2025
WatchPAT400 (WP400)
K250460 · Itamar Medical , Ltd. · Sep 2025
Somfit D
K252383 · Compumedics Limited · Aug 2025
Happy Health Home Sleep Test
K242224 · Happy Health, Inc. · Jun 2025