Cleared Traditional

K182429 - Masimo O3 Regional Oximeter System

K182429 is an FDA 510(k) clearance for Masimo O3 Regional Oximeter System, manufactured by Masimo Corporation. The device is a Class 2 Neurology device with product code MUD cleared through the Traditional 510(k) pathway after a 274-day FDA review.

K182429 · Masimo Corporation · Neurology device
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Jun 2019
Decision
274d
Days
Class 2
Risk

K182429 is an FDA 510(k) clearance for the Masimo O3 Regional Oximeter System. Classified as Oximeter, Tissue Saturation (product code MUD), Class II - Special Controls.

Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on June 7, 2019 after a review of 274 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.2700 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Masimo Corporation devices

FDA 510(k) Submission Details - K182429

510(k) Number K182429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2018
Decision Date June 07, 2019
Days to Decision 274 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 148d · This submission: 274d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUD Device Classification - Class 2, Special Controls

Product Code MUD Oximeter, Tissue Saturation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
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 Neurology devices follow this clearance model.

Regulatory Peers - MUD Oximeter, Tissue Saturation

All 58
Devices cleared under the same product code (MUD) and FDA review panel - the closest regulatory comparables to K182429.
FORE-SIGHT ELITE Tissue Oximeter Module
K190270 · Cas Medical Systems, Inc. · Oct 2019
T-Stat 2.0 Microvascular Tissue Oximeter
K192322 · Spectros Corporation · Sep 2019
Intra.Ox 2.0 Handheld Tissue Oximeter
K191676 · Vioptix, Inc. · Sep 2019
SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface
K190560 · Nonin Medical, Inc. · May 2019
INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor
K182868 · Covidien, LLC · Jan 2019
Presygen/si-1
K171245 · Christie Medical Holdings, Inc. · Aug 2018