Class Class II
Radius VSM and Accessories (K223498)
Description
Radius VSM and Accessories by Masimo Corporation, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223498
Clearance Date2023-06-01
Clearance TypeTraditional
Product CodeMHX
Regulation Number870.1025
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223498
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. Radius VSM and Accessories (K223498) cites 4 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K193626 | Masimo Rad-97 Pulse CO-Oximeter and Accessories | Masimo Corporation | 2020 |
| K191882 | Masimo Centroid System | Masimo Corporation | 2020 |
| K200494 | CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCA... | GE Healthcare | 2020 |
| K193242 | Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Rad... | Masimo Corporation | 2020 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250757 | Radius VSM and Accessories | Masimo Corporation | 2025 |
Trace the full predicate network for K223498
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.