Cleared Traditional

K080238 - MASIMO RAINBOW SET RADICAL 7 PULSE CO-O...

K080238 is an FDA 510(k) clearance for MASIMO RAINBOW SET RADICAL 7 PULSE CO-O..., 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 102-day FDA review.

K080238 · Masimo Corporation · Anesthesiology device
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Optimized for regulatory review, auditing and printing
May 2008
Decision
102d
Days
Class 2
Risk

K080238 is an FDA 510(k) clearance for the MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PUL.... Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on May 12, 2008 after a review of 102 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 - K080238

510(k) Number K080238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2008
Decision Date May 12, 2008
Days to Decision 102 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
38d faster than avg
Panel avg: 140d · This submission: 102d
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 477
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K080238.
WRIST PULSE OXIMETER MD300W
K081125 · Beijing Choice Electronic Technololgy Co., Ltd. · Jul 2008
FINGER PULSE OXIMETER, MODEL 9560
K081285 · Nonin Medical, Inc. · Jun 2008
NONIN MEDICAL, INC., MODEL 7500 DIGITAL PULSE OXIMETER
K080255 · Nonin Medical, Inc. · May 2008
FORE-SIGHT, MC-2000 SERIES
K073036 · Cas Medical Systems, Inc. · Feb 2008
MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER AND ACCESSORIES
K073024 · Masimo Corporation · Feb 2008
FINGERTIP PULSE OXIMETER, MODEL MD300I
K072825 · Beijing Choice Electronic Technololgy Co., Ltd. · Jan 2008