# K053244: Licox IT2 Complete Brain Tunneling Probe Kit

- Pathway: 510(k) (Special)
- Applicant: Integra Lifesciences Corp.
- Decided: May 10, 2006 after 170 days
- Product code: GWM (Device, Monitoring, Intracranial Pressure)
- Device class: 2
- Regulation: 21 CFR 882.1620
- Recalls of this device: 1 (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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040235: Licox Pmo Brain Monitoring System, Integra LifeSciences Corporation (2004) Summary page 1.

## 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.

## Indications for use
The LICOX 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/K053244
Methodology: https://510kreport.com/methodology