# K243220: Onera STS 2 (ONERA STS 2)

- Pathway: 510(k) (Traditional)
- Applicant: Onera B.V.
- Decided: Jul 3, 2025 after 269 days
- Product code: MNR (Ventilatory Effort Recorder)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K913396 (1992). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223573: Onera Sleep Test System (Onera STS), Onera B.V. (2023) Summary page 6.

## Indications for use
Onera STS 2 measures and records multiple physiological parameters from a patient during a sleep study, which are used by clinicians to decide on the diagnosis of sleep disorders. Onera STS 2 is intended to be used on a patient who has been prescribed a polysomnography study by a healthcare professional. The device is designed to be used under the direction of a physician or trained technician but applied by a layperson. The recorded data will be made available to the healthcare professional to assist in the diagnosis of sleep disorders. The device is intended to be used for adults. The device is not a life supporting physiological monitor.

Source page: https://510kreport.com/device/K243220
Methodology: https://510kreport.com/methodology