Cleared Traditional

K253417 - Masimo Root Monitoring System

K253417 is an FDA 510(k) clearance for Masimo Root Monitoring System, manufactured by Masimo Corporation. The device is a Class 2 Anesthesiology device with product code MWI cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K253417 · Masimo Corporation · Anesthesiology device
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Aug 2026
Decision
315d
Days
Class 2
Risk

K253417 is an FDA 510(k) clearance for the Masimo Root Monitoring System. 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 August 12, 2026 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2300 - the FDA anesthesiology and respiratory device 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Masimo Corporation devices

FDA 510(k) Submission Details - K253417

510(k) Number K253417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2025
Decision Date August 12, 2026
Days to Decision 315 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
175d slower than avg
Panel avg: 140d · This submission: 315d
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 Anesthesiology devices follow this clearance model.

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

All 253
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K253417.
Vital Signs Monitor (CLEO2)
K260438 · Infinium Medical, Inc. · Aug 2026
Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)
K253196 · Midmark Corporation · Jun 2026
c-med0 alpha
K253436 · Cosinuss GmbH · Apr 2026
WAVE Clinical Platform (2.0.000)
K250135 · Baxter Healthcare Corp/ Excel Medical · Jan 2026
QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)
K241766 · Fysicon BV · Aug 2025
Empatica Health Monitoring Platform
K242737 · Empatica S.R.L. · Jun 2025