Cleared Traditional

K091241 - MASIMO RAINBOW SET RADICAL 7 PULSE CO-O...

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

K091241 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 193-day FDA review.

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

FDA 510(k) Submission Details - K091241

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.

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 K091241.
FINGERTIP PULSE OXIMETER, MODEL MD300CA ND300CA
K092652 · Beijing Choice Electronic Technololgy Co., Ltd. · Jan 2010
MD300C318 FINGERTIP PULSE OXIMETER
K092620 · Beijing Choice Electronic Technololgy Co., Ltd. · Dec 2009
H100B PULSE OXIMETER
K092727 · Edan Instruments, Inc. · Dec 2009
REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES
K092101 · Nonin Medical, Inc. · Oct 2009
MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8
K092838 · Masimo Corporation · Oct 2009
MODEL 6000 TWO PARAMETER BEDSIDE MONITOR
K091787 · Ivy Biomedical Systems, Inc. · Oct 2009