Cleared Special

MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER AND ACCESSORIES (K073024) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K073024 · Masimo Corporation · Anesthesiology device
Download Printable Device Report (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.

View all Masimo Corporation devices

Submission Details

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.

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 239
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K073024.
MASIMO RAINBOW SET RADCHECK PULSE CO-OXIMETER, RADCHECK, RAD 57 SPOT CHECK
K082052 · Masimo Corporation · Oct 2008
RAINBOW ADHESIVE CO-OXIMETRY SENSOR, MODELS RI-25-L, RI-25, RI-20 AND RI-20-L
K081659 · Masimo Corporation · Sep 2008
MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER
K080238 · Masimo Corporation · May 2008
PM-60 PULSE OXIMETER
K072581 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jan 2008
PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR
K072235 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2007
MODIFICATION TO: RAINBOW ADHESIVE CO-OXIMETRY SENSORS
K071024 · Masimo Corporation · Jun 2007