Cleared Special

K003244 - MODIFICATION TO MASIMO SET RADICAL PULS...

K003244 is an FDA 510(k) clearance for MODIFICATION TO MASIMO SET RADICAL PULS..., manufactured by Masimo Corp.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Special 510(k) pathway after a 22-day FDA review.

K003244 · Masimo Corp. · Anesthesiology device
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Nov 2000
Decision
22d
Days
Class 2
Risk

K003244 is an FDA 510(k) clearance for the MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERI.... Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Masimo Corp. (Irvine, US). The FDA issued a Cleared decision on November 8, 2000 after a review of 22 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. 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 Corp. devices

FDA 510(k) Submission Details - K003244

510(k) Number K003244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2000
Decision Date November 08, 2000
Days to Decision 22 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
118d faster than avg
Panel avg: 140d · This submission: 22d
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 453
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K003244.
DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES
K010463 · Datex-Ohmeda, Inc. · Mar 2001
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K010419 · Masimo Corp. · Mar 2001
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K003167 · Masimo Corp. · Nov 2000
SOLAR SPO2 MODULE WITH MASIMO SET
K002957 · General Electric Medical Systems Information Techn · Oct 2000
MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500
K002690 · Nonin Medical, Inc. · Oct 2000
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENORS OXIMETER
K002939 · Masimo Corp. · Oct 2000