Cleared Special

K111888 - MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORS

K111888 is an FDA 510(k) clearance for MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXI..., 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 84-day FDA review.

K111888 · Masimo Corporation · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
84d
Days
Class 2
Risk

K111888 is an FDA 510(k) clearance for the MASIMO LNOP/LNCS/M-LNCS MULTISITE-L 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 September 23, 2011 after a review of 84 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.

FDA 510(k) Submission Details - K111888

510(k) Number K111888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2011
Decision Date September 23, 2011
Days to Decision 84 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
56d faster than avg
Panel avg: 140d · This submission: 84d
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 K111888.
PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1
K111617 · Acare Technology Co., Ltd. · Dec 2011
VTRUST FINGER TYPE PULSE OXIMETER
K110893 · Taidoc Technology Corporation · Nov 2011
MASIMO RESPOSABLE SPO2 SERIES OXIMETRY SENSORS, MASIMO LNCS / M-LNCS OXIMETRY SENSORS
K111621 · Masimo Corporation · Oct 2011
VITAL SIGNS MONITOR
K112465 · Advanced Instruments, Inc. · Sep 2011
TRUSIGNAL R SPO2 PEDITIP SENSOR
K103802 · GE Healthcare Finland Oy · Aug 2011
DIXTAL DZ-4100 SERIES PULSE OXIMETER
K103285 · Dixtal Medical, Inc. · Jul 2011