510(k) K250757

Radius VSM and Accessories by Masimo Corporation — Product Code MHX

K250757 is an FDA 510(k) premarket notification submitted by Masimo Corporation for the device "Radius VSM and Accessories". The FDA issued a decision of Substantially Equivalent on May 29, 2025. The device falls under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.1025. Masimo Corporation has at least 10 other 510(k) clearances on record.