Cleared Traditional

Masimo O3 Regional Oximeter System (K201432) - FDA 510(k) Clearance

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

K201432 · Masimo Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2020
Decision
89d
Days
Class 2
Risk

K201432 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 August 29, 2020 after a review of 89 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Masimo Corporation devices

Submission Details

510(k) Number K201432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2020
Decision Date August 29, 2020
Days to Decision 89 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
26d faster than avg
Panel avg: 115d · This submission: 89d
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
NCT04002960 Completed Interventional Industry-sponsored

Desaturation Validation of INVSENSOR00036

23
Patients (actual)
1
Site
Other
Purpose
Open label
Masking
Condition studied Healthy
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Sponsor Masimo Corporation (industry)
Started 2019-06-14 → Primary completion 2019-07-05
Primary outcome
Trending Accuracy of INVSENSOR00036
View full study on ClinicalTrials.gov

Regulatory Peers - MUD Oximeter, Tissue Saturation

All 73
Devices cleared under the same product code (MUD) and FDA review panel - the closest regulatory comparables to K201432.
Spectrum-2
K254129 · Neko Health AB · May 2026
Masimo O3 Regional Oximeter
K243324 · Masimo Corporation · Jul 2025
Lap.Ox™ Laparoscopic Tissue Oximeter
K250519 · Vioptix, Inc. · Jun 2025
Cerebral Autoregulation Index (CAI) Algorithm
K240596 · Edwards Lifesciences · Oct 2024
ODI-Tech
K241393 · Odi Medical AS · Aug 2024
SnapshotNIR model KD205
K240601 · Kent Imaging, Inc. · Apr 2024