510(k) K253417

Masimo Root Monitoring System by Masimo Corporation — Product Code MWI

K253417 is an FDA 510(k) premarket notification submitted by Masimo Corporation for the device "Masimo Root Monitoring System". The FDA issued a decision of Substantially Equivalent on August 12, 2026. The device falls under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.2300. Masimo Corporation has at least 10 other 510(k) clearances on record.