Cleared Traditional

K214072 - Masimo O3 Regional Oximeter System (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence.

K214072 · Masimo Corporation · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
May 2022
Decision
130d
Days
Class 2
Risk

K214072 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 6, 2022 after a review of 130 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 870.2700 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Masimo Corporation devices

Submission Details

510(k) Number K214072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2021
Decision Date May 06, 2022
Days to Decision 130 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 114d · This submission: 130d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT04584788 Completed Interventional Industry-sponsored

Validation of the O3 Regional Somatic Tissue Oxygenation Monitor

A Single-Center, Prospective Study in Healthy Volunteers for Validation of the O3 Regional Somatic Tissue Oxygenation Monitor

37
Patients (actual)
1
Site
Other
Purpose
Open label
Masking
Condition studied Oxygen Deficiency
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Sponsor Masimo Corporation (industry)
Started 2020-11-30 → Primary completion 2021-06-02
Primary outcome
Accuracy of O3 Sensor by ARMS Calculation of Percent rSO2
View full study on ClinicalTrials.gov

Regulatory Peers - MUD Oximeter, Tissue Saturation

All 72
Devices cleared under the same product code (MUD) and FDA review panel - the closest regulatory comparables to K214072.
Masimo O3 Regional Oximeter
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K250519 · Vioptix, Inc. · Jun 2025
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ODI-Tech
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OxiplexTS200
K232385 · Iss Medical, Inc. · Mar 2024