Cleared Traditional

K160526 - Masimo O3 Regional Oximeter System

K160526 is the FDA 510(k) clearance for Masimo O3 Regional Oximeter System by Masimo Corporation. It is a Class 2 Cardiovascular device (product code MUD) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K160526 · Masimo Corporation · Cardiovascular device
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Jun 2016
Decision
105d
Days
Class 2
Risk

K160526 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 9, 2016 after a review of 105 days - within the typical 510(k) review window.

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.

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Submission Details

510(k) Number K160526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2016
Decision Date June 09, 2016
Days to Decision 105 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
20d faster than avg
Panel avg: 125d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.