Cleared Special

K073024 - MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER AND ACCESSORIES

K073024 is an FDA 510(k) clearance for MASIMO RAINBOW SET RAD 87 PULSE CO-OXIM..., manufactured by Masimo Corporation. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Special 510(k) pathway after a 105-day FDA review.

K073024 · Masimo Corporation · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
105d
Days
Class 2
Risk

K073024 is an FDA 510(k) clearance for the MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER AND ACCESSORIES. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on February 8, 2008 after a review of 105 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K073024

510(k) Number K073024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2007
Decision Date February 08, 2008
Days to Decision 105 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
35d faster than avg
Panel avg: 140d · This submission: 105d
Pathway characteristics
Modification to existing cleared device.

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 687
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K073024.
FINGERTIP PULSE OXIMETER, MODEL CMS-50C
K073454 · Contec Medical System Co., Ltd. · May 2008
MEDIAID M960 SERIES, VITAL SIGNS MONITOR AND MEDIAID M900 SERIES, PULSE OXIMETER
K071642 · Mediaid, Inc. · May 2008
FORE-SIGHT, MC-2000 SERIES
K073036 · Cas Medical Systems, Inc. · Feb 2008
FINGERTIP PULSE OXIMETER, MODEL MD300I
K072825 · Beijing Choice Electronic Technololgy Co., Ltd. · Jan 2008
PM-60 PULSE OXIMETER
K072581 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jan 2008
MEDIAID PULSE OXIMETER M30 AND M34
K071610 · Mediaid, Inc. · Nov 2007