Cleared Traditional

K243220 - Onera STS 2 (ONERA STS 2)

K243220 is an FDA 510(k) clearance for Onera STS 2 (ONERA STS 2), manufactured by Onera B.V.. The device is a Class 2 Neurology device with product code MNR cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K243220 · Onera B.V. · Neurology device
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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

FDA 510(k) Submission Details - K243220

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.

MNR Device Classification - Class 2, Special Controls

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 135
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