Class Class II
Masimo O3 Regional Oximeter (K243324)
Description
Masimo O3 Regional Oximeter by Masimo Corporation, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243324
Clearance Date2025-07-17
Clearance TypeTraditional
Product CodeMUD
Regulation Number870.2700
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243324
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. Masimo O3 Regional Oximeter (K243324) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K214072 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2022 |
Trace the full predicate network for K243324
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.