Cleared Special

K110723 - M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS

K110723 is an FDA 510(k) clearance for M-LNCS OXIMETRY SENSORS, manufactured by Masimo Corporation. The device is a Class 2 Anesthesiology device with product code NLF cleared through the Special 510(k) pathway after a 134-day FDA review.

K110723 · Masimo Corporation · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
134d
Days
Class 2
Risk

K110723 is an FDA 510(k) clearance for the M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS. Classified as Oximeter, Reprocessed (product code NLF), Class II - Special Controls.

Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on July 28, 2011 after a review of 134 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 - K110723

510(k) Number K110723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2011
Decision Date July 28, 2011
Days to Decision 134 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
6d faster than avg
Panel avg: 140d · This submission: 134d
Pathway characteristics
Modification to existing cleared device.

NLF Device Classification - Class 2, Special Controls

Product Code NLF Oximeter, Reprocessed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
Definition Same As Dqa Except Reprocessed. Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf).
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 - NLF Oximeter, Reprocessed

All 26
Devices cleared under the same product code (NLF) and FDA review panel - the closest regulatory comparables to K110723.
Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor
K201699 · Surgical Instrument and Savings Inc (Dba Medline Renewal) · Jul 2020
Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors
K191018 · Surgical Instrument Service and Savings, Inc. · Jul 2019
RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE
K111773 · Renu Medical, Inc. · Nov 2011
REPROCESSED PULSE OXIMETER SENSORS
K102560 · Sterilmed, Inc. · Feb 2011
MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE
K101280 · Midwest Reprocessing Center, LLC · Oct 2010
REPROCESSED PULSE OXIMETER SENSORS
K092368 · Sterilmed, Inc. · Nov 2009