Cleared Traditional

K191882 - Masimo Centroid System (FDA 510(k) Clearance)

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

K191882 · Masimo Corporation · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2020
Decision
282d
Days
Class 2
Risk

K191882 is an FDA 510(k) clearance for the Masimo Centroid 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 April 22, 2020 after a review of 282 days - an extended review cycle.

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. Standard predicate reliance. 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

Submission Details

510(k) Number K191882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2019
Decision Date April 22, 2020
Days to Decision 282 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
143d slower than avg
Panel avg: 139d · This submission: 282d
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 Anesthesiology devices follow this clearance model.

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

All 304
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K191882.
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
WARD-CSS (v1.2.x)
K241958 · Ward 24/7 Aps · Feb 2025
iCare APP
K243146 · Ihealth Labs, Inc. · Feb 2025