Cleared Traditional

Masimo Rad-97 and Accessories (K191059) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence.

K191059 · Masimo Corporation · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Dec 2019
Decision
249d
Days
Class 2
Risk

K191059 is an FDA 510(k) clearance for the Masimo Rad-97 and Accessories. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on December 27, 2019 after a review of 249 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2300 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Masimo Corporation devices

Submission Details

510(k) Number K191059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2019
Decision Date December 27, 2019
Days to Decision 249 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d slower than avg
Panel avg: 140d · This submission: 249d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 Anesthesiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03570255 Completed Interventional Industry-sponsored

Feasibility and Performance Evaluation for INVSENSOR00024

Feasibility and Performance Evaluation of INVSENSOR00024

28
Patients (actual)
1
Site
Other
Purpose
Open label
Masking
Condition studied Evaluation of SpO2 Performance
Study design Single group
Eligibility All sexes · Healthy volunteers accepted
Sponsor Masimo Corporation (industry)
Started 2018-06-25 → Primary completion 2019-11-08
Primary outcome
Accuracy of Oxygen Saturation (SpO2) Measurement by RMS Calculation
View full study on ClinicalTrials.gov

Regulatory Peers - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 96
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K191059.
Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories
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PeraMobile and PeraWatch
K183370 · Perahealth, Inc. · Sep 2019