510(k) · Cleared
Recalled · Class II · 2015Integra Licox PTO2 Monitor
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 Aug 30, 2013 as substantially equivalent to K002765 (Integra Neurosciences, 2000) and 3 other predicates after a 127-day review. Its family tree reaches back 3 generations to 2000. It has been recalled 5 times.
- Decided
- Aug 30, 2013
- Review
- 127 days
- Class
- Class II
- Product code
- GWM
- Recalls
- 5
- Predicates
- 4
Its longest line of descent runs back 3 generations to K002765 (2000). 13 ancestors in all, the oldest K813459 (1982). 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 deviceK131184 Integra Licox PTO2 MonitorIntegra Lifesciences Corp. · 2013
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) | K131184 | Integra Licox PTO2 Monitor | Integra Lifesciences Corp. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2012 | 2 | 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? (4)
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…GWM -807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed * LICOX Brain Oxygen Monitoring System, CMP® Monitor and IMC® Systems - K002765 * LICOX PMO BRAIN MONITORING SYSTEM- K040235 * INTEGRA CAM INO ICP MONITOR- K 121573 . INTEGRA CAMINO FLEX VENT… | 2000 |
| * | K040235 | Licox Pmo Brain Monitoring SystemSummary page 1…device(s) to which equivalence is claimed * LICOX Brain Oxygen Monitoring System, CMP® Monitor and IMC® Systems - K002765 * LICOX PMO BRAIN MONITORING SYSTEM- K040235 * INTEGRA CAM INO ICP MONITOR- K 121573 . INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING… | 2004 |
| * | K121573 | Integra Camino Icp MonitorSummary page 1…* LICOX Brain Oxygen Monitoring System, CMP® Monitor and IMC® Systems - K002765 * LICOX PMO BRAIN MONITORING SYSTEM- K040235 * INTEGRA CAM INO ICP MONITOR- K 121573 . INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRORA CAMINO FLEX ADAPTER- K121 1… | 2012 |
| * | K121159 | Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit with Intrgra Camino…Summary page 1…5 * INTEGRA CAM INO ICP MONITOR- K 121573 . INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRORA CAMINO FLEX ADAPTER- K121 159 807.92(a)(4) - Device description The Integra®i Licox® PtO2 monitor instrument is a diagnostic tool for continuously monitoring… | 2012 |
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 |
|---|---|---|---|---|
| Apr 14, 2015 | Class II | Z-1619-2015 | Device Design | Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM 02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible speaker malfunctions. |
| Apr 14, 2015 | Class II | Z-1618-2015 | Device Design | Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible speaker malfunctions. |
| Apr 14, 2015 | Class II | Z-1620-2015 | Device Design | Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM 02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible speaker malfunctions. |
| Aug 18, 2014 | Class II | Z-0201-2015 | Device Design | Integra LifeSciences Corporation received 2 complaints that the USB port on the Licox Pt02 monitor does not consistently provide the user the ability to extract the Pt02 trend data according to the User's Manual for the device. |
| Apr 16, 2014 | Class II | Z-1675-2014 | Under Investigation by firm | Integra LifeSciences has identified through a small number of complaints that some lot numbers of Licox Test Kits (Catalog Number BC10R) may provide erroneous "calibration test failure" message when they are used with the Licox PtO2… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 6 of the 13 ancestors have a recall of any class.
- 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. 2013, this device’s year, is highlighted.
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 Integra Licox PtO 2 Monitor measures oxygen partial pressure (PtO 2) and temperature in brain tissue and these parameters are used together as an aid in the determination of the perfusion status of cerebral tissue local to sensor placement. Monitor values are relative within an individual, and should not be used as the sole basis for determining a 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/K131184 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131184: Integra Licox PTO2 Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131184
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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