Cleared Traditional

Masimo Root Monitoring System and Accessories (K171121) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K171121 · Masimo Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
214d
Days
Class 2
Risk

K171121 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 November 17, 2017 after a review of 214 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

Submission Details

510(k) Number K171121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2017
Decision Date November 17, 2017
Days to Decision 214 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
89d slower than avg
Panel avg: 125d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 116
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