Cleared Traditional

MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER (K091241) - FDA 510(k) Clearance

Also marketed or referenced as:
RAD 87 PULSE CO-OXIMETER

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K091241 · Masimo Corporation · Anesthesiology device
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Nov 2009
Decision
193d
Days
Class 2
Risk

K091241 is an FDA 510(k) clearance for the MASIMO RAINBOW SET RADICAL 7 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 November 6, 2009 after a review of 193 days - an extended review cycle.

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

Submission Details

510(k) Number K091241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2009
Decision Date November 06, 2009
Days to Decision 193 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
53d slower than avg
Panel avg: 140d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 218
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K091241.
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K100617 · Masimo Corporation · May 2010
LNCS OXIMETRY SENSORS, REPROCESSED LNCS OXIMETRY SENSORS
K094046 · Masimo Corporation · May 2010
H100B PULSE OXIMETER
K092727 · Edan Instruments, Inc. · Dec 2009
VITAL SIGNS MONITOR
K083821 · Edan Instruments, Inc. · May 2009
N-600X WITH SPD, OXIMAX N-600X
K083325 · Covidien · Mar 2009
PM-60 PULSE OXIMETER
K072581 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jan 2008