# K002765: Licox CMP Monitor-AC3.1, Licox Imc Oxygen Catheters-CC1,CC1.SB Luicox Imc Introducer Kits-IM,IM2,IM3,II1 Licoximc Tempe

- Pathway: 510(k) (Traditional)
- Applicant: Integra Neurosciences
- Decided: Nov 24, 2000 after 80 days
- Product code: GWM (Device, Monitoring, Intracranial Pressure)
- Device class: 2
- Regulation: 21 CFR 882.1620
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
20 later devices descend from it; 9 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K130529: Raumedic-Pto-Monitoring-System (2013), 4 descendants of its own
- K013005: Act 11 MP Ventricular Catheter (2002), 4 descendants of its own
- K041838: MPS (or MPS-T) (2005), 3 descendants of its own
- K020285: Cma Cerebral Tissue Monitoring System (2002), 3 descendants of its own
- K020558: Licox CC1.G2 Brain Oxygen Catheter-Microprobe (2002), 3 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.
- Dec 17, 2010 · Not classified · Z-1518-2011: Certain LICOX CMP Tissue Oxygen Monitors could allow for underestimation of temperature values.
- Jan 21, 2005 · Not classified · Z-0622-05: LICOX Model C8.B temperature probes manufactured by GMS mbH, an Integra company, may exhibit progen (endotoxin) levels above the FDA limit of 2.15 endotoxin units per device. Elevated endotoxin levels

Source page: https://510kreport.com/device/K002765
Methodology: https://510kreport.com/methodology