Cleared Traditional

Onera STS 2 (ONERA STS 2)

K243220 · Onera B.V. · Neurology
Jul 2025
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K243220 is an FDA 510(k) clearance for the Onera STS 2 (ONERA STS 2), a Ventilatory Effort Recorder (Class II — Special Controls, product code MNR), submitted by Onera B.V. (Eindhoven, NL). The FDA issued a Cleared decision on July 3, 2025, 269 days after receiving the submission on October 7, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number K243220 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code MNR — Ventilatory Effort Recorder
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.2375