510(k) · Cleared
Recalled · Class II · 2014Licox IT2 Complete Brain Tunneling Probe Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Lifesciences Corp. · GWM Device, Monitoring, Intracranial Pressure
Cleared on May 10, 2006 as substantially equivalent to K040235 (Integra LifeSciences Corporation, 2004) after a 170-day review. Its family tree reaches back 3 generations to 2000. It has been recalled once.
- Decided
- May 10, 2006
- Review
- 170 days
- Class
- Class II
- Product code
- GWM
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002765 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK002765 Licox CMP Monitor-AC3.1, Licox Imc Oxygen Catheters-CC1,CC1.SB…Integra Neurosciences · 2000 · Recalled
- 2 generations backK020558 Licox CC1.G2 Brain Oxygen Catheter-MicroprobeIntegra Neurosciences · 2002
- 1 generation backK040235 Licox Pmo Brain Monitoring SystemIntegra LifeSciences Corporation · 2004 · Recalled
- This deviceK053244 Licox IT2 Complete Brain Tunneling Probe KitIntegra Lifesciences Corp. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002765 | Licox CMP Monitor-AC3.1, Licox Imc Oxygen Catheters-CC1,CC1.SB Luicox Imc… | Integra Neurosciences | 2000 | 3 |
| −2 | K020558 | Licox CC1.G2 Brain Oxygen Catheter-Microprobe | Integra Neurosciences | 2002 | — |
| −1 | K040235 | Licox Pmo Brain Monitoring System | Integra LifeSciences Corporation | 2004 | 12 |
| 0 (this device) | K053244 | Licox IT2 Complete Brain Tunneling Probe Kit | Integra Lifesciences Corp. | 2006 | — |
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? (1)
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 |
|---|---|---|---|
| * | K040235 | Licox Pmo Brain Monitoring SystemSummary page 1…e the same indications for use and perform to the same specifications as the components used with the LICOX® 1T2 Complete Brain Tunneling Probe Kit (510(k) K040235). Device Description: The LICOX® 1T2 Complete Brain Tunneling Probe Kit is intended for use with the LICOX Brain Ox… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 1 other device also cites its predicate K040235.
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 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/K053244 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053244: Licox IT2 Complete Brain Tunneling Probe Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053244
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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