# K210593: Onera Sleep Test System (Onera STS)

- Pathway: 510(k) (Traditional)
- Applicant: Onera B.V.
- Decided: Apr 6, 2022 after 401 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: 7 generations back to K913396 (1992). 28 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122516: Embletta MPR, Embla Systems (2013) Summary page 5.

## Most influential descendants
- K223573: Onera Sleep Test System (Onera STS) (2023), 1 descendant of its own
- K260050: WRAP System (2026), 0 descendants of its own
- K243220: Onera STS 2 (ONERA STS 2) (2025), 0 descendants of its own

## Indications for use
Onera STS measures and records multiple physiological parameters from a patient during a sleep study which are used by clinicians to make a decision on the diagnosis of sleep disorders. Onera STS is intended to be used on a patient, who has been prescribed a sleep 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 a healthcare professional to assist in the diagnosis of sleep disorders. The device is intended to be used for adults.

Source page: https://510kreport.com/device/K210593
Methodology: https://510kreport.com/methodology