# K962928: Combined Intracranial Pressure-Temperature Sensing System (Icp/)

- Pathway: 510(k) (Traditional)
- Applicant: Camino Neurocare, Inc.
- Decided: Dec 20, 1996 after 144 days
- Product code: GWM (Device, Monitoring, Intracranial Pressure)
- Device class: 2
- Regulation: 21 CFR 882.1620
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K813459 (1982). 5 ancestors in all.
39 later devices descend from it; 9 cite it directly.
0 of 45 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.
- K813459: Reusable & Disposable Temp. Probes, Electromedics, Inc. (1982) Summary page 1.
- K914735: Ventricular Pressure Monitoring Kit, Model 110-4HM, Camino Laboratories, Inc. (1992) Summary page 1.
- K893232: Model V420 Direct Pressure Monitor & 427 Waveform, Camino Laboratories, Inc. (1989) Summary page 2.
- K842616: Spacelabs Alpha PC Patient Computer, Spacelabs, Inc. (1984) Summary page 2.

## Most influential descendants
- K980380: Neurotrend Multiparameter Sensor, C7004S, to Operate with Paratrend 7+ Multiparameter Sensor, MPM7001S, and Satellite MS (1999), 27 descendants of its own
- K050702: Neurosystems 1TM Monitor (2005), 17 descendants of its own
- K061640: Integra Mobius Multi-Modality Monitoring System (2006), 15 descendants of its own
- K080217: Component Neuromonitoring System (2008), 14 descendants of its own
- K092573: Nihon Kohden QP-160AK Eeg Trend Program (2010), 7 descendants of its own

## Recalls of this device
- Nov 26, 2013 · Class II · Z-0602-2014: Integra became aware through a complaint from a single non-US customer that if the optional SYS/DIAS mode is used on CAM01 monitor that contains Mod 4 Firmware, the displayed values for the systolic a
- Oct 20, 2011 · Not classified · Z-0944-2012: Some of the connector cables associated with Integra's intracerebral pressure (ICP) monitors may cause temporary interference with the ICP waveform on the monitor display.

## Indications for use
Use by a qualified neurosurgeon for direct measurement of intracranial pressure and temperature in the parenchyma. Use by a qualified neurosurgeon for direct measurement of intracranial pressure and temperature in the ventricles and cerebrospinal fluid drainage. Intended to be used with an external drainage system as indicated by individual manufacturers.

Source page: https://510kreport.com/device/K962928
Methodology: https://510kreport.com/methodology