Cleared Special

Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor (K201770) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K201770 · Masimo Corporation · Anesthesiology device
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Sep 2020
Decision
87d
Days
Class 2
Risk

K201770 is an FDA 510(k) clearance for the Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable se.... Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on September 24, 2020 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Masimo Corporation devices

Submission Details

510(k) Number K201770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2020
Decision Date September 24, 2020
Days to Decision 87 days
Submission Type Special
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
53d faster than avg
Panel avg: 140d · This submission: 87d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DQA Oximeter
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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - DQA Oximeter

All 170
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K201770.
Pulse Oximeter
K202173 · Shenzhen AOJ Medical Technology Co., Ltd. · Dec 2020
Pulse Oximeter
K201294 · Guangdong Long Yao Electronic Technology Co., Ltd. · Nov 2020
Spo2 Sensor
K202851 · Jkh USA, LLC · Nov 2020
Pulse Oximeter
K200414 · Shenzhen Aeon Technology Co., Ltd. · Sep 2020
Reusable and Disposable SpO2 Sensors
K201360 · Xinkang Medical Instrument Co. , Ltd. · Aug 2020
GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable
K201179 · Covidien, LLC · Jul 2020