510(k) · Cleared
Recalled · Class II · 2015Camino 110-4B Olm Intracranial Pressure Mnitoring Kit; Camino 110-4G Post Craniotomy Subdural Pressure Monitoring Kit; C
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 Dec 20, 2010 as substantially equivalent to K853864 (Camino Laboratories, Inc., 1986) and 2 other predicates after an 80-day review. Its family tree reaches back 2 generations to 1982. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Dec 20, 2010
- Review
- 80 days
- Class
- Class II
- Product code
- GWM
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 2 generations to K813459 (1982). 7 ancestors in all. 2 later devices descend from it, 1 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 deviceK102875 Camino 110-4B Olm Intracranial Pressure Mnitoring Kit; Camino 110-4G…Integra LifeSciences Corporation · 2010
- 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
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 | 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) | K102875 | Camino 110-4B Olm Intracranial Pressure Mnitoring Kit; Camino 110-4G Post… | Integra LifeSciences Corporation | 2010 | — |
| +1 | K162108 | Pressio 2 ICP Monitoring System | Sophysa SA | 2017 | 3 |
| +2 | K252241 | Pressio 3 Multi-parameter Neuromonitoring System | Sophysa | 2026 | — |
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 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 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 13.0 · 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? (3)
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 |
|---|---|---|---|
| * | K853864 | Intracranial Pressure Monitoring Kit 070Summary page 1…acranial Pressure Device Class: Class 11, under 21 CFR 882.1620 Classification Panel: Neurology Product Code: GWM Predicate Devices: K853864 Intracranial Pressure Monitoring Kit, Model 070 (Camino I10-413 and Camino 11l0-4G)… | 1986 |
| * | K962928 | Combined Intracranial Pressure-Temperature Sensing System (Icp/)Summary page 1…Predicate Devices: K853864 Intracranial Pressure Monitoring Kit, Model 070 (Camino I10-413 and Camino 11l0-4G) K962928 Combined Intracranial Pressure-Temperature Sensing (Camino I110-413T) K022553… | 1996 |
| * | K022553 | Camino Intracranial Pressure Monitoring Catheter with Licox Imc Bolt Fitting, Model 110-4LSummary page 1…Camino 11l0-4G) K962928 Combined Intracranial Pressure-Temperature Sensing (Camino I110-413T) K022553 Camino® Intracranial Pressure Monitoring Catheter with LICO)? 1MGBolt Fitting, Model I110-4L (Camino 1… | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162108 | Pressio 2 ICP Monitoring System | 2017 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 27, 2015 | Class II | Z-1815-2015 | Under Investigation by firm | Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Catheters because they may have been incorrectly assembled. Specifically, the o-ring in the bolt adapter may be in the wrong location and as a result, there is… |
| Jul 9, 2014 | Class II | Z-2072-2014 | No Marketing Application | Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Kits because of revised labelling to indicate they are unsafe in an MR environment. |
| Sep 10, 2013 | Class II | Z-0117-2014 | Under Investigation by firm | Integra LifeSciences has identified through an internal evaluation that in order to comply with US FDA requirements, certain Camino Intracranial Pressure Monitoring Kits require additional labelling to indicate they are UNSAFE in an MR… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 14.7 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K162108 (Sophysa SA, 2017) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K853864.
How does its category compare?
All GWM devicesGWM Device, Monitoring, Intracranial Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 use of the OLM Intracranial Pressure Monitoring Kit by a qualified neurosurgeon is indicated when direct measurement of intracranial pressure in the parenchyma or the subarachnoid space, is clinically important. The use of the Post Craniotomy Subdural Pressure Monitoring Catheter by a qualified neurosurgeon is indicated when direct pressure measurement in the subdural space, post craniotomy, is clinically important. The Camino Intracranial Pressure…
Read the full statement (147 words)
The use of the OLM Intracranial Pressure Monitoring Kit by a qualified neurosurgeon is indicated when direct measurement of intracranial pressure in the parenchyma or the subarachnoid space, is clinically important.
The use of the Post Craniotomy Subdural Pressure Monitoring Catheter by a qualified neurosurgeon is indicated when direct pressure measurement in the subdural space, post craniotomy, is clinically important.
The Camino Intracranial Pressure Temperature Monitoring Kit is indicated for use by qualified neurosurgeons for measurement of intracranial pressure and temperature in the parenchyma.
The Camino® Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting, Model 110-4L is indicated for use by a qualified Neurosurgeon when direct measurement of intracranial pressure in the parenchyma or subarachnoid space is clinically important. The Camino® Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting, Model 110-4L is intended to be used only through a Licox Brain Oxygen Monitoring System Bolt.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102875 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102875: Camino 110-4B Olm Intracranial Pressure Mnitoring Kit; Camino 110-4G Post Craniotomy Subdural Pressure Monitoring Kit; C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102875
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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