510(k) · Cleared
ClearedLicox CC1.G2 Brain Oxygen Catheter-Microprobe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Neurosciences · GWM Device, Monitoring, Intracranial Pressure
Cleared on Mar 21, 2002 as substantially equivalent to K002765 (Integra Neurosciences, 2000) after a 29-day review. Its family tree reaches back 1 generation to 2000. 3 later devices descend from it.
- Decided
- Mar 21, 2002
- Review
- 29 days
- Class
- Class II
- Product code
- GWM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002765 (2000). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK002765 Licox CMP Monitor-AC3.1, Licox Imc Oxygen Catheters-CC1,CC1.SB…Integra Neurosciences · 2000 · Recalled
- This deviceK020558 Licox CC1.G2 Brain Oxygen Catheter-MicroprobeIntegra Neurosciences · 2002
- Descendant · cites it directly · 2 of its ownK040235 Licox Pmo Brain Monitoring SystemIntegra LifeSciences Corporation · 2004 · Recalled
- Descendant · 2 generations on · 0 of its ownK131184 Integra Licox PTO2 MonitorIntegra Lifesciences Corp. · 2013 · Recalled
- Descendant · 2 generations on · 0 of its ownK053244 Licox IT2 Complete Brain Tunneling Probe KitIntegra Lifesciences Corp. · 2006 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K040235Licox Pmo Brain Monitoring SystemIntegra LifeSciences Corporation · 2004 · cites it directly2descendants
- K131184Integra Licox PTO2 MonitorIntegra Lifesciences Corp. · 2013 · 2 generations on0descendants
- K053244Licox IT2 Complete Brain Tunneling Probe KitIntegra Lifesciences Corp. · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002765 | Licox CMP Monitor-AC3.1, Licox Imc Oxygen Catheters-CC1,CC1.SB Luicox Imc… | Integra Neurosciences | 2000 | 3 |
| 0 (this device) | K020558 | Licox CC1.G2 Brain Oxygen Catheter-Microprobe | Integra Neurosciences | 2002 | — |
| +1 | K040235 | Licox Pmo Brain Monitoring System | Integra LifeSciences Corporation | 2004 | 12 |
| +2 | K131184 | Integra Licox PTO2 Monitor | Integra Lifesciences Corp. | 2013 | 5 |
| +2 | 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 |
|---|---|---|
| 2004 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K002765 | Licox CMP Monitor-AC3.1, Licox Imc Oxygen Catheters-CC1,CC1.SB Luicox Imc Introducer…Summary page 1…® CC1.G2 product was designed to have the same indications for use and perform to the same specifications as the LICOX® CC1.SB Brain Oxygen Catheter- Microprobe (510(k) K002765). Device Description: The LICOX® CC1.G2 is a brain oxygen catheter-microprobe intended for use with the LICOX Brain Oxygen Moni… | 2000 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040235 | Licox Pmo Brain Monitoring System | 2004 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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® CC1.G2 is a brain oxygen catheter-microprobe intended for use with the LICOX Brain Oxygen Monitoring System. 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020558 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020558: Licox CC1.G2 Brain Oxygen Catheter-Microprobe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020558
Report an extraction error
Are you the manufacturer?
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