Cleared Traditional

K162603 - Masimo O3 Regional Oximeter System

K162603 is an FDA 510(k) clearance for Masimo O3 Regional Oximeter System, manufactured by Masimo Corporation. The device is a Class 2 Cardiovascular device with product code MUD cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K162603 · Masimo Corporation · Cardiovascular device
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May 2017
Decision
249d
Days
Class 2
Risk

K162603 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 May 26, 2017 after a review of 249 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2700 - 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 - K162603

510(k) Number K162603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2016
Decision Date May 26, 2017
Days to Decision 249 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
124d slower than avg
Panel avg: 125d · This submission: 249d
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - MUD Oximeter, Tissue Saturation

All 38
Devices cleared under the same product code (MUD) and FDA review panel - the closest regulatory comparables to K162603.
Presygen/si-1
K171245 · Christie Medical Holdings, Inc. · Aug 2018
Clarifi Imaging System
K181623 · Modulated Imaging, Inc. · Jul 2018
FORE-SIGHT ELITE Module Tissue Oximeter
K180003 · Cas Medical Systems, Inc. · May 2018
Masimo O3 Regional Oximeter System
K160526 · Masimo Corporation · Jun 2016
SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg)
K151305 · Nonin Medical, Inc. · Aug 2015
FORE-SIGHT Elite Absolute Tissue Oximeter
K143675 · Cas Medical Systems, Inc. · Apr 2015