Class Class II
Onera STS 2 (ONERA STS 2) (K243220)
Description
Onera STS 2 (ONERA STS 2) by Onera B.V., an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243220
Clearance Date2025-07-03
Clearance TypeTraditional
Product CodeMNR
Regulation Number868.2375
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243220
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Onera STS 2 (ONERA STS 2) (K243220) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223573 | Onera Sleep Test System (Onera STS) | Onera B.V. | 2023 |
Trace the full predicate network for K243220
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.