# K040235: Licox Pmo Brain Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Integra LifeSciences Corporation
- Decided: Apr 20, 2004 after 78 days
- Product code: GWM (Device, Monitoring, Intracranial Pressure)
- Device class: 2
- Regulation: 21 CFR 882.1620
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K002765 (2000). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002765: Licox CMP Monitor-AC3.1, Licox Imc Oxygen Catheters-CC1,CC1.SB Luicox Imc Introducer Kits-IM,IM2,IM3,II1 Licoximc Tempe, Integra Neurosciences (2000) Summary page 1.
- K020558: Licox CC1.G2 Brain Oxygen Catheter-Microprobe, Integra Neurosciences (2002) Summary page 1.

## Most influential descendants
- K131184: Integra Licox PTO2 Monitor (2013), 0 descendants of its own
- K053244: Licox IT2 Complete Brain Tunneling Probe Kit (2006), 0 descendants of its own

## Recalls of this device
- Nov 7, 2014 · Class II · Z-0831-2015: Due to a complaint, it was determined that multiple lots of Licox catheters manufactured since October 29, 2013 contained a smart card which was programmed with an inaccurate lkN2 value.
- Jun 11, 2013 · Class II · Z-0061-2014: Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the 
- Jun 11, 2013 · Class II · Z-0062-2014: Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the 
- Jun 11, 2013 · Class II · Z-0054-2014: Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the 
- Jun 11, 2013 · Class II · Z-0060-2014: Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the 
- Jun 11, 2013 · Class II · Z-0055-2014: Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the 
- Jun 11, 2013 · Class II · Z-0056-2014: Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the 
- Jun 11, 2013 · Class II · Z-0057-2014: Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the 
- Jun 11, 2013 · Class II · Z-0059-2014: Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the 
- Jun 11, 2013 · Class II · Z-0063-2014: Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the 
- Sep 15, 2010 · Not classified · Z-0161-2011: Incorrect expiration date - The outer boxes of the IP2P Licox Complete Kit for Cerebral Pressure, Temperature and ICP Monitoring Probes, Lot 250210A are labeled with an incorrect shelf life date (10 m
- Feb 18, 2010 · Not classified · Z-1422-2010: One probe that had failed a product release test was inadvertently packaged and released into inventory in Integra's distribution center.

## Indications for use
The LICOX PMO Brain Oxygen Monitoring System measures intracranial oxygen and temperature and is intended as an adjunct monitor of trends of these parameters, indicating the perfusion status of cerebral tissue local to sensor placement. LICOX System values are relative within an individual, and should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide data additional to that obtained by current clinical practice in cases where hypoxia or ischemia are a concern.

Source page: https://510kreport.com/device/K040235
Methodology: https://510kreport.com/methodology