Cleared Traditional

K153225 - Masimo Root Monitoring System and Accessories

K153225 is an FDA 510(k) clearance for Masimo Root Monitoring System and Acces..., manufactured by Masimo Corporation. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Traditional 510(k) pathway after a 228-day FDA review.

K153225 · Masimo Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
228d
Days
Class 2
Risk

K153225 is an FDA 510(k) clearance for the Masimo Root Monitoring System and Accessories. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on June 21, 2016 after a review of 228 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Masimo Corporation devices

FDA 510(k) Submission Details - K153225

510(k) Number K153225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2015
Decision Date June 21, 2016
Days to Decision 228 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d slower than avg
Panel avg: 125d · This submission: 228d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MWI Device Classification - Class 2, Special Controls

Product Code MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 178
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K153225.
Unity Network ID
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Vital Sync Informatics Manager & Virtual Patient Monitoring Platform
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VITAL SIGNS MONITOR
K153135 · Guangdong Biolight Meditech Co., Ltd. · Feb 2016
Masimo Root Vital Signs Monitoring System and Accessories
K151644 · Masimo Corporation · Feb 2016
Expression MR400 MRI Patient Monitoring System
K152330 · Invivo Corporation · Dec 2015