Cleared Special

K101896 - MASIMO LNCS/M-LNCS OXIMETRY SENSORS

K101896 is an FDA 510(k) clearance for MASIMO LNCS/M-LNCS OXIMETRY SENSORS, 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 106-day FDA review.

K101896 · Masimo Corporation · Anesthesiology device
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Oct 2010
Decision
106d
Days
Class 2
Risk

K101896 is an FDA 510(k) clearance for the MASIMO LNCS/M-LNCS OXIMETRY SENSORS. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on October 21, 2010 after a review of 106 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

FDA 510(k) Submission Details - K101896

510(k) Number K101896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2010
Decision Date October 21, 2010
Days to Decision 106 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
34d faster than avg
Panel avg: 140d · This submission: 106d
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 477
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K101896.
MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES
K101577 · Beijing Choice Electronic Technololgy Co., Ltd. · Dec 2010
VITAL SIGNS MONITOR MODEL M3B
K101539 · Edan Instruments, Inc. · Nov 2010
MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1
K101031 · Masimo Corporation · Nov 2010
TRUSIGNAL SPO2 FINGERTIP SENSOR
K101871 · GE Healthcare Finland Oy · Oct 2010
HANDHELD PULSE OXIMETER MODEL M800
K101694 · Guangdong Biolight Meditech Co., Ltd. · Sep 2010
INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL
K101600 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Aug 2010