510(k) · Cleared
Recalled · Class II · 2015Integra Camino Icp Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intrgra Lifesciences Corporation · GWM Device, Monitoring, Intracranial Pressure
Cleared on Sep 10, 2012 as substantially equivalent to K962928 (Camino Neurocare, Inc., 1996) after a 104-day review. Its family tree reaches back 2 generations to 1982. 4 later devices descend from it. It has been recalled 3 times.
- Decided
- Sep 10, 2012
- Review
- 104 days
- Class
- Class II
- Product code
- GWM
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K813459 (1982). 6 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK813459 Reusable & Disposable Temp. ProbesElectromedics, Inc. · 1982
- 1 generation backK962928 Combined Intracranial Pressure-Temperature Sensing System (Icp/)Camino Neurocare, Inc. · 1996 · Recalled
- This deviceK121573 Integra Camino Icp MonitorIntrgra Lifesciences Corporation · 2012
- Descendant · cites it directly · 1 of its ownK162108 Pressio 2 ICP Monitoring SystemSophysa SA · 2017 · Recalled
- Descendant · 2 generations on · 0 of its ownK252241 Pressio 3 Multi-parameter Neuromonitoring SystemSophysa · 2026
- Descendant · cites it directly · 0 of its ownK171666 MPR2 logO DATALOGGERRaumedic AG · 2017
- Descendant · cites it directly · 0 of its ownK131184 Integra Licox PTO2 MonitorIntegra Lifesciences Corp. · 2013 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K162108Pressio 2 ICP Monitoring SystemSophysa SA · 2017 · cites it directly1descendant
- K252241Pressio 3 Multi-parameter Neuromonitoring SystemSophysa · 2026 · 2 generations on0descendants
- K171666MPR2 logO DATALOGGERRaumedic AG · 2017 · cites it directly0descendants
- K131184Integra Licox PTO2 MonitorIntegra Lifesciences Corp. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K813459 | Reusable & Disposable Temp. Probes | Electromedics, Inc. | 1982 | — |
| −1 | K962928 | Combined Intracranial Pressure-Temperature Sensing System (Icp/) | Camino Neurocare, Inc. | 1996 | 2 |
| 0 (this device) | K121573 | Integra Camino Icp Monitor | Intrgra Lifesciences Corporation | 2012 | — |
| +1 | K162108 | Pressio 2 ICP Monitoring System | Sophysa SA | 2017 | 3 |
| +2 | K252241 | Pressio 3 Multi-parameter Neuromonitoring System | Sophysa | 2026 | — |
| +1 | K171666 | MPR2 logO DATALOGGER | Raumedic AG | 2017 | — |
| +1 | K131184 | Integra Licox PTO2 Monitor | Integra Lifesciences Corp. | 2013 | 5 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2017 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K962928 | Combined Intracranial Pressure-Temperature Sensing System (Icp/)Summary page 1…1I, under 21 CFR 882.1620 Product Code(s) GWM 807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed Camnino(& Multi Parameter Monitor - K962928 807.92(a)(4) - Device description The Integrag Camino®R ICP Monitor is a compact, portable device that provides tools for continu… | 1996 |
What descends from it? (4)
3 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 |
|---|---|---|---|---|
| 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 3 companies; a new generation was cleared every 15.7 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K162108 (Sophysa SA, 2017) has gone furthest, with 1 descendant of its own.
- 8 other devices also cite its predicate K962928.
How does its category compare?
All GWM devicesGWM Device, Monitoring, Intracranial Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Camino ICP Monitor is indicated for use by qualified neurosurgeons or neurointensivists for measurement of intracranial pressure and temperature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121573 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121573: Integra Camino Icp Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121573
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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