# K102875: Camino 110-4B Olm Intracranial Pressure Mnitoring Kit; Camino 110-4G Post Craniotomy Subdural Pressure Monitoring Kit; C

- Pathway: 510(k) (Traditional)
- Applicant: Integra LifeSciences Corporation
- Decided: Dec 20, 2010 after 80 days
- Product code: GWM (Device, Monitoring, Intracranial Pressure)
- Device class: 2
- Regulation: 21 CFR 882.1620
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K813459 (1982). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K853864: Intracranial Pressure Monitoring Kit 070, Camino Laboratories, Inc. (1986) Summary page 1.
- K962928: Combined Intracranial Pressure-Temperature Sensing System (Icp/), Camino Neurocare, Inc. (1996) Summary page 1.
- K022553: Camino Intracranial Pressure Monitoring Catheter with Licox Imc Bolt Fitting, Model 110-4L, Integra Neurosciences (2002) Summary page 1.

## Most influential descendants
- K162108: Pressio 2 ICP Monitoring System (2017), 1 descendant of its own
- K252241: Pressio 3 Multi-parameter Neuromonitoring System (2026), 0 descendants of its own

## Recalls of this device
- May 27, 2015 · Class II · Z-1815-2015: 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 wro
- Jul 9, 2014 · Class II · Z-2072-2014: 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: 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 t

## Indications for use
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.

Source page: https://510kreport.com/device/K102875
Methodology: https://510kreport.com/methodology