# K131184: Integra Licox PTO2 Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Integra Lifesciences Corp.
- Decided: Aug 30, 2013 after 127 days
- Product code: GWM (Device, Monitoring, Intracranial Pressure)
- Device class: 2
- Regulation: 21 CFR 882.1620
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K002765 (2000). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 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.
- K040235: Licox Pmo Brain Monitoring System, Integra LifeSciences Corporation (2004) Summary page 1.
- K121573: Integra Camino Icp Monitor, Intrgra Lifesciences Corporation (2012) Summary page 1.
- K121159: Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit with Intrgra Camino Flex Adapter, Integra Lifescience Corportation (2012) Summary page 1.

## Recalls of this device
- Apr 14, 2015 · Class II · Z-1619-2015: Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM 02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible speaker malfunctions.
- Apr 14, 2015 · Class II · Z-1618-2015: Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible speaker malfunctions.
- Apr 14, 2015 · Class II · Z-1620-2015: Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM 02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible speaker malfunctions.
- Aug 18, 2014 · Class II · Z-0201-2015: Integra LifeSciences Corporation received 2 complaints that the USB port on the Licox Pt02 monitor does not consistently provide the user the ability to extract the Pt02 trend data according to the Us
- Apr 16, 2014 · Class II · Z-1675-2014: Integra LifeSciences has identified through a small number of complaints that some lot numbers of Licox Test Kits (Catalog Number BC10R) may provide erroneous "calibration test failure" message when t

## Indications for use
The Integra Licox PtO 2 Monitor measures oxygen partial pressure (PtO 2) and temperature in brain tissue and these parameters are used together as an aid in the determination of the perfusion status of cerebral tissue local to sensor placement. Monitor values are relative within an individual, and should not be used as the sole basis for determining a 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/K131184
Methodology: https://510kreport.com/methodology