Onera STS 2 (ONERA STS 2)

FDA 510(k) K243220 · Onera B.V.

Substantially Equivalent

510(k) numberK243220

Submission

Device name
Onera STS 2 (ONERA STS 2)
Applicant
Onera B.V.
Eindhoven, NL
Received
October 7, 2024
Decision date
July 3, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MNR – Ventilatory Effort Recorder
Device class
Class II (moderate risk)
Regulation
21 CFR 868.2375
Specialty
Anesthesiology

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K254042WatchPAT SWMNR · Traditional Itamar Medical , Ltd.07/31/2026SE
K260050WRAP SystemMNR · Traditional Huneo, LLC07/15/2026SE
K253148RX-1 SleepMNR · Traditional Vivaquant, Inc. Dba Rhythm Express06/22/2026SE
K252628CassieMNR · Traditional Wesper, Inc.04/27/2026SE
K252497Sansa HsatMNR · Traditional Huxley Medical12/10/2025SE
K250882Sansa HsatMNR · Traditional Huxley Medical10/29/2025SE
K250460WatchPAT400 (WP400)MNR · Traditional Itamar Medical , Ltd.09/05/2025SE
K252383Somfit DMNR · Special Compumedics Limited08/28/2025SE
K242224Happy Health Home Sleep TestMNR · Traditional Happy Health, Inc.06/18/2025SE
K243092AcuPebble Ox (200)MNR · Traditional Acurable Limited03/19/2025SE

More from Acurable Limited

510(k)DeviceDecision
K253668Onera SleepMap (SLEEPMAP)OLZ · Traditional 03/08/2026SE
K223573Onera Sleep Test System (Onera STS)MNR · Traditional 08/18/2023SE
K210593Onera Sleep Test System (Onera STS)MNR · Traditional 04/06/2022SE

Questions and answers

When was Onera STS 2 (ONERA STS 2) cleared by the FDA?

Onera STS 2 (ONERA STS 2) (K243220) received a 510(k) decision of Substantially Equivalent on July 3, 2025, 269 days after the submission was received.

What is the product code of K243220?

The FDA product code is MNR – Ventilatory Effort Recorder, a Class II (moderate risk) device regulated under 21 CFR 868.2375.