Cleared Traditional

Masimo Rad-97 and Accessories (K183697) - FDA 510(k) Clearance

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

K183697 · Masimo Corporation · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2019
Decision
135d
Days
Class 2
Risk

K183697 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 May 15, 2019 after a review of 135 days - within the typical 510(k) review window.

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 K183697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2018
Decision Date May 15, 2019
Days to Decision 135 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
5d faster than avg
Panel avg: 140d · This submission: 135d
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
NCT03783780 Completed Interventional Industry-sponsored

Desaturation Validation of INVSENSOR00031

21
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 2018-12-11 → Primary completion 2018-12-18
Primary outcome
Oxygen Saturation (SpO2) Accuracy of Sensor by Arms Calculation During Non-motion
Secondary outcome
Oxygen Saturation (SpO2) Accuracy of Sensor by Arms Calculation During Motion
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 K183697.
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