# Onera B.V.

- Location (FDA's records): Eindhoven, NL
- FDA decisions: 4 (2022–2026): 4 510(k) clearances
- Product codes: MNR (3), OLZ (1)
- 510(k) review time since 2016: median 265 days, against 174 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 4 (2 its own); citations of its devices by later devices: 3 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ensodata, Inc.: 1 (https://510kreport.com/company/ensodata)
- Embla Systems: 1 (https://510kreport.com/company/embla-systems)

## Firms that cite its devices most
- Huneo, LLC: 1 (https://510kreport.com/company/huneo)

## Its most-cited devices
- K210593: Onera Sleep Test System (Onera STS) (2022), cited by 2
- K223573: Onera Sleep Test System (Onera STS) (2023), cited by 1

## Recent decisions
- K253668: Onera SleepMap (SLEEPMAP) (Mar 8, 2026)
- K243220: Onera STS 2 (ONERA STS 2) (Jul 3, 2025)
- K223573: Onera Sleep Test System (Onera STS) (Aug 18, 2023)
- K210593: Onera Sleep Test System (Onera STS) (Apr 6, 2022)

Source page: https://510kreport.com/company/onera