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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K253417
Device Name Masimo Root Monitoring System
Applicant
Masimo Corporation
52 Discovery
Irvine,  CA  92618
Applicant Contact Sindura Penubarthi
Correspondent
Masimo Corporation
52 Discovery
Irvine,  CA  92618
Correspondent Contact Sindura Penubarthi
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Codes
BZQ   CCK   DPZ   DQA   DXG  
DXN   FLL   GWQ   GXY   JKS   KMI  
OLT   OLW   OMC   ORT  
Date Received10/01/2025
Decision Date 08/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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