Cleared Traditional

K243324 - Masimo O3 Regional Oximeter (FDA 510(k) Clearance)

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

K243324 · Masimo Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
267d
Days
Class 2
Risk

K243324 is an FDA 510(k) clearance for the Masimo O3 Regional Oximeter. 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 July 17, 2025 after a review of 267 days - an extended review 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: 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 K243324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2024
Decision Date July 17, 2025
Days to Decision 267 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
153d slower than avg
Panel avg: 114d · This submission: 267d
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
NCT03396835 Completed Interventional Industry-sponsored

Desaturation Validation of INVSENSOR00009

16
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 2017-12-18 → Primary completion 2018-01-16
Primary outcome
Trending Regional Oxygen Saturation Accuracy of the INVSENSOR00009 Relative to the Control Sensor by Arms Calculation
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 K243324.
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
OxiplexTS200
K232385 · Iss Medical, Inc. · Mar 2024
Intra.Ox™ 2.0 Handheld Tissue Oximeter
K233488 · Vioptix, Inc. · Feb 2024