510(k) · Cleared
Recalled · Class II · 2014Licox Pmo Brain Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra LifeSciences Corporation · GWM Device, Monitoring, Intracranial Pressure
Cleared on Apr 20, 2004 as substantially equivalent to K002765 (Integra Neurosciences, 2000) and 1 other predicate after a 78-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it. It has been recalled 12 times.
- Decided
- Apr 20, 2004
- Review
- 78 days
- Class
- Class II
- Product code
- GWM
- Recalls
- 12
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002765 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK002765 Licox CMP Monitor-AC3.1, Licox Imc Oxygen Catheters-CC1,CC1.SB…Integra Neurosciences · 2000 · Recalled
- 1 generation backK020558 Licox CC1.G2 Brain Oxygen Catheter-MicroprobeIntegra Neurosciences · 2002
- This deviceK040235 Licox Pmo Brain Monitoring SystemIntegra LifeSciences Corporation · 2004
- Descendant · cites it directly · 0 of its ownK131184 Integra Licox PTO2 MonitorIntegra Lifesciences Corp. · 2013 · Recalled
- Descendant · cites it directly · 0 of its ownK053244 Licox IT2 Complete Brain Tunneling Probe KitIntegra Lifesciences Corp. · 2006 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002765 | Licox CMP Monitor-AC3.1, Licox Imc Oxygen Catheters-CC1,CC1.SB Luicox Imc… | Integra Neurosciences | 2000 | 3 |
| −1 | K020558 | Licox CC1.G2 Brain Oxygen Catheter-Microprobe | Integra Neurosciences | 2002 | — |
| 0 (this device) | K040235 | Licox Pmo Brain Monitoring System | Integra LifeSciences Corporation | 2004 | — |
| +1 | K131184 | Integra Licox PTO2 Monitor | Integra Lifesciences Corp. | 2013 | 5 |
| +1 | K053244 | Licox IT2 Complete Brain Tunneling Probe Kit | Integra Lifesciences Corp. | 2006 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GWM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GWM device
- #1 K252241 Pressio 3 Multi-parameter Neuromonitoring Systemscore 12.9 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K002765 | Licox CMP Monitor-AC3.1, Licox Imc Oxygen Catheters-CC1,CC1.SB Luicox Imc Introducer…Summary page 1…antially equivalent to those of a legally marketed predicate device, the LICOX Brain Oxygen Monitoring System, which was cleared to market under 510(k) K002765 and 510(k) K020558. Both devices were designed and are manufactured by the same company, GMSmbH, Kiel-Mielkend… | 2000 |
| * | K020558 | Licox CC1.G2 Brain Oxygen Catheter-MicroprobeSummary page 1…to those of a legally marketed predicate device, the LICOX Brain Oxygen Monitoring System, which was cleared to market under 510(k) K002765 and 510(k) K020558. Both devices were designed and are manufactured by the same company, GMSmbH, Kiel-Mielkendorf, Germany, which… | 2002 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 7, 2014 | Class II | Z-0831-2015 | Device Design | 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 | Nonconforming Material/Component | 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 set screw on the drill bit. |
| Jun 11, 2013 | Class II | Z-0062-2014 | Nonconforming Material/Component | 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 set screw on the drill bit. |
| Jun 11, 2013 | Class II | Z-0054-2014 | Nonconforming Material/Component | 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 set screw on the drill bit. |
| Jun 11, 2013 | Class II | Z-0060-2014 | Nonconforming Material/Component | 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 set screw on the drill bit. |
| Jun 11, 2013 | Class II | Z-0055-2014 | Nonconforming Material/Component | 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 set screw on the drill bit. |
| Jun 11, 2013 | Class II | Z-0056-2014 | Nonconforming Material/Component | 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 set screw on the drill bit. |
| Jun 11, 2013 | Class II | Z-0057-2014 | Nonconforming Material/Component | 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 set screw on the drill bit. |
| Jun 11, 2013 | Class II | Z-0059-2014 | Nonconforming Material/Component | 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 set screw on the drill bit. |
| Jun 11, 2013 | Class II | Z-0063-2014 | Nonconforming Material/Component | 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 set screw on the drill bit. |
| Sep 15, 2010 | Not classified | Z-0161-2011 | Employee error | 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 months too long). |
| Feb 18, 2010 | Not classified | Z-1422-2010 | Process control | One probe that had failed a product release test was inadvertently packaged and released into inventory in Integra's distribution center. |
The 5 latest of 12 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K131184 (Integra Lifesciences Corp., 2013) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K002765.
How does its category compare?
All GWM devicesGWM Device, Monitoring, Intracranial Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GWM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWM
30in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWM
3in 2025
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · GWM
441in 2025
MAUDE reports naming product code GWM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 126 |
| 2008 | 2 | — | 1 | 105 |
| 2009 | 1 | — | 0 | 117 |
| 2010 | 2 | — | 9 | 104 |
| 2011 | 3 | 123 | 6 | 184 |
| 2012 | 4 | 100 | 1 | 151 |
| 2013 | 2 | — | 12 | 120 |
| 2014 | 2 | — | 2 | 360 |
| 2015 | 0 | — | 0 | 486 |
| 2016 | 3 | 192 | 0 | 419 |
| 2017 | 3 | 37 | 0 | 445 |
| 2018 | 1 | — | 0 | 302 |
| 2019 | 2 | — | 1 | 260 |
| 2020 | 3 | 30 | 0 | 268 |
| 2021 | 2 | — | 0 | 211 |
| 2022 | 0 | — | 0 | 424 |
| 2023 | 0 | — | 1 (1) | 744 |
| 2024 | 2 | — | 4 (2) | 641 |
| 2025 | 1 | — | 3 | 441 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040235 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040235: Licox Pmo Brain Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040235
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026