Cleared Special

K012992 - MASIMO SET RADICAL PULSE OXIMETER WITH ...

K012992 is an FDA 510(k) clearance for MASIMO SET RADICAL PULSE OXIMETER WITH ..., 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 27-day FDA review.

K012992 · Masimo Corp. · Anesthesiology device
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Oct 2001
Decision
27d
Days
Class 2
Risk

K012992 is an FDA 510(k) clearance for the MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND MASIMO SERIES OF SENSORS .... Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Masimo Corp. (Irvine, US). The FDA issued a Cleared decision on October 3, 2001 after a review of 27 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 - K012992

510(k) Number K012992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2001
Decision Date October 03, 2001
Days to Decision 27 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
113d faster than avg
Panel avg: 140d · This submission: 27d
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 K012992.
NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE (NIBP) MONITOR
K013319 · Nonin Medical, Inc. · Jan 2002
FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE
K013273 · Fukuda Denshi USA, Inc. · Dec 2001
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K013792 · Masimo Corp. · Dec 2001
ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM
K011320 · Hitachi Medical Systems America, Inc. · Aug 2001
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K011851 · Masimo Corp. · Jul 2001
DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (WITH TRUTRAK+MOTION CORRECTION PERFORMANCE
K011670 · Datex-Ohmeda · Jun 2001