Class Class II
AcuPebble OX100 (K222950)
Description
AcuPebble OX100 by Acurable Limited, an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222950
Clearance Date2023-02-03
Clearance TypeTraditional
Product CodeMNR
Regulation Number868.2375
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222950
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. AcuPebble OX100 (K222950) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K210480 | AcuPebble SA | Acurable Limited | 2021 |
| K191031 | NightOwl | Ectosense NV | 2020 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243092 | AcuPebble Ox (200) | Acurable Limited | 2025 |
Trace the full predicate network for K222950
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.