Cleared Special

K011851 - MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES

K011851 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 28-day FDA review.

K011851 · Masimo Corp. · Anesthesiology device
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Jul 2001
Decision
28d
Days
Class 2
Risk

K011851 is an FDA 510(k) clearance for the MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AN.... Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Masimo Corp. (Irvine, US). The FDA issued a Cleared decision on July 11, 2001 after a review of 28 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 - K011851

510(k) Number K011851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2001
Decision Date July 11, 2001
Days to Decision 28 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
112d faster than avg
Panel avg: 140d · This submission: 28d
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 665
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K011851.
MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER AND ACCESSORIES
K012533 · Osi Medical, Inc. · Aug 2001
ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM
K011320 · Hitachi Medical Systems America, Inc. · Aug 2001
MINOLTA PULSOX-3SI, PULSOX-3IA, PULSOX-3LI
K010413 · Konica Minolta Sensing, Inc. · Aug 2001
DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (WITH TRUTRAK+MOTION CORRECTION PERFORMANCE
K011670 · Datex-Ohmeda · Jun 2001
BCI 3403 SLEEP SCREENING PULSE OXIMETER
K011156 · Bci, Inc. · Jun 2001
MEDLEY SP02 MODULE, MODEL 8220
K010966 · Alaris Medical Systems, Inc. · Jun 2001