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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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 687
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K101896.
VITAL SIGNS MONITOR MODEL M3B
K101539 · Edan Instruments, Inc. · Nov 2010
MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1
K101031 · Masimo Corporation · Nov 2010
CHARMCARE TABLETOP PULSE OXIMETER
K092641 · Charmcare Co., Ltd. · Oct 2010
NELLCOR COMPATIBLE REUSABLE SPO2 SOFT-FINGER SENSOR, MODEL T100A-090103
K100077 · Solaris Medical Technology, Inc. · Oct 2010
TRUSIGNAL SPO2 FINGERTIP SENSOR
K101871 · GE Healthcare Finland Oy · Oct 2010
MODEL SB100II FINGER PULSE OXIMETER
K101568 · Atlantean · Sep 2010