Class Class II
Radius VSM and Accessories (K250757)
Description
Radius VSM and Accessories by Masimo Corporation, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250757
Clearance Date2025-05-29
Clearance TypeTraditional
Product CodeMHX
Regulation Number870.1025
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250757
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 (K250757) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223498 | Radius VSM and Accessories | Masimo Corporation | 2023 |
| K171801 | IntelliVue Patient Monitor MX100 and Multi-Measurement Modu... | Philips Medizin Systeme Boeblingen ... | 2017 |
Trace the full predicate network for K250757
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.