Cleared Traditional

K162675 - Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter

K162675 is an FDA 510(k) clearance for Masimo Rainbow SET Intellivue Module Pu..., manufactured by Masimo Corporation. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K162675 · Masimo Corporation · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
93d
Days
Class 2
Risk

K162675 is an FDA 510(k) clearance for the Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on December 28, 2016 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - 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

FDA 510(k) Submission Details - K162675

510(k) Number K162675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2016
Decision Date December 28, 2016
Days to Decision 93 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
47d faster than avg
Panel avg: 140d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

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 686
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K162675.
Guardian Angel GA1000 Digital Vital Sign Monitoring System
K162580 · Taiwan Aulisa Medical Devices Technologies, Inc. · Mar 2017
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K162014 · Bluepoint Medical GmbH & Co. KG · Feb 2017
Caremed Reusable & Disposable SPO2 Sensors
K153184 · Shenzhen Caremed Medical Technology Co., Ltd. · Jan 2017
Model X-100C CO-Met™ Oximetry System
K160231 · Nonin Medical, Inc. · Dec 2016
Masimo Disposable Transflectance Forehead Sensor
K160940 · Masimo Corporation · Nov 2016
Fingertip Pulse Oximeter A310
K153021 · Amemo, Inc. · Nov 2016