510(k) · Cleared

Recalled · Class II · 2013

Combined Intracranial Pressure-Temperature Sensing System (Icp/)

K962928510(k) TraditionalCleared Dec 20, 1996144-day reviewClass II21 CFR 882.1620Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Camino Neurocare, Inc. · GWM Device, Monitoring, Intracranial Pressure

Cleared on Dec 20, 1996 as substantially equivalent to K853864 (Camino Laboratories, Inc., 1986) and 4 other predicates after a 144-day review. Its family tree reaches back 1 generation to 1982. 39 later devices descend from it. It has been recalled 2 times.

Decided: Dec 20, 1996
Review: 144 days
Class: Class II
Product code: GWM
Recalls: 2
Predicates: 5

Its longest line of descent runs back 1 generation to K813459 (1982). 5 ancestors in all. 39 later devices descend from it, 9 citing it directly.

By dateBy generation

Root · 1 generation backK813459 Reusable & Disposable Temp. ProbesElectromedics, Inc. · 1982
This deviceK962928 Combined Intracranial Pressure-Temperature Sensing System (Icp/)Camino Neurocare, Inc. · 1996
Descendant · cites it directly · 27 of its ownK980380 Neurotrend Multiparameter Sensor, C7004S, to Operate with Paratrend…Diametrics Medical, Ltd. · 1999
Descendant · 2 generations on · 17 of its ownK050702 Neurosystems 1TM MonitorNeurosystems, LLC · 2005
Descendant · 3 generations on · 15 of its ownK061640 Integra Mobius Multi-Modality Monitoring SystemIntegra LifeSciences Corporation · 2006
Descendant · 4 generations on · 14 of its ownK080217 Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · Recalled
Descendant · 5 generations on · 7 of its ownK092573 Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010

Showing 5 of 39 descendants. See all descendants

Descendants cleared per year

1999high 4 (2012) · low 0 (2000)2026

Most influential descendants

Showing 5 of 39 · See all

K980380Neurotrend Multiparameter Sensor, C7004S, to Operate with Paratrend 7+ Multiparameter…Diametrics Medical, Ltd. · 1999 · cites it directly27descendants
K050702Neurosystems 1TM MonitorNeurosystems, LLC · 2005 · 2 generations on17descendants
K061640Integra Mobius Multi-Modality Monitoring SystemIntegra LifeSciences Corporation · 2006 · 3 generations on15descendants
K080217Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · 4 generations on14descendants
K092573Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010 · 5 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K813459	Reusable & Disposable Temp. Probes	Electromedics, Inc.	1982	—
0 (this device)	K962928	Combined Intracranial Pressure-Temperature Sensing System (Icp/)	Camino Neurocare, Inc.	1996	—
+1	K980380	Neurotrend Multiparameter Sensor, C7004S, to Operate with Paratrend 7+…	Diametrics Medical, Ltd.	1999	—
+2	K050702	Neurosystems 1TM Monitor	Neurosystems, LLC	2005	—
+3	K061640	Integra Mobius Multi-Modality Monitoring System	Integra LifeSciences Corporation	2006	—
+4	K080217	Component Neuromonitoring System	Moberg Research, Inc.	2008	1
+5	K092573	Nihon Kohden QP-160AK Eeg Trend Program	Nihon Kohden America, Inc.	2010	—

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
1999	1	0
2001	1	0
2002	1	0
2003	1	0
2005	1	0
2006	2	0
2008	3	0
2009	1	0
2010	3	0
2011	1	0
2012	4	0
2013	2	0
2014	1	0
2015	1	0
2016	2	0
2017	3	0
2018	1	0
2019	2	0
2020	2	0
2022	1	0
2024	1	0
2025	2	0
2026	2	0

FIG. 1 — Lineage of K962928, 1982–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (5)

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	Applicant	Decided	Recalls
*	K853864	Intracranial Pressure Monitoring Kit 070 Summary page 1 …ing System Camino NeuroCare™ Intracranial Pressure-Temperature Monitoring Kit: Model 110-4BT is equivalent to: Camino, Intracranial Pressure Monitoring Kit, Model 070, 853864C Electromedics, Inc., Esophageal, Rectal, Nasopharyngeal Probe, Model 2403, K813459A. Model 110-4HMT is equivalent to: Camino, M…	Camino Laboratories, Inc.	1986	—
*	K813459	Reusable & Disposable Temp. Probes Summary page 1 …del 110-4BT is equivalent to: Camino, Intracranial Pressure Monitoring Kit, Model 070, 853864C Electromedics, Inc., Esophageal, Rectal, Nasopharyngeal Probe, Model 2403, K813459A. Model 110-4HMT is equivalent to: Camino, Micro Ventricular Pressure Monitoring Kit, Model 110-HM, K914735 Electromedics, Inc.…	Electromedics, Inc.	1982	—
*	K914735	Ventricular Pressure Monitoring Kit, Model 110-4HM Summary page 1 …Inc., Esophageal, Rectal, Nasopharyngeal Probe, Model 2403, K813459A. Model 110-4HMT is equivalent to: Camino, Micro Ventricular Pressure Monitoring Kit, Model 110-HM, K914735 Electromedics, Inc., Esophageal, Rectal, Nasopharyngeal Probe, Model 2403, K813459A e [y > ‘A-' (] 9! Premark…	Camino Laboratories, Inc.	1992	—
*	K893232	Model V420 Direct Pressure Monitor & 427 Waveform Summary page 2 …tification - Camino NeuroCare™ 3. PREDICATE DEVICE: Camino NeuroCare™ Multi Parameter Monitor: Model MPM is equivalent to: Camino, Direct Pressure Monitor, Model V420, K893232 SpaceLabs, Patient Monitor, Model Alpha PC Patient Computer, K842616. 4. DEVICE DESCRIPTION: The Intracranial Pressure-Temperat…	Camino Laboratories, Inc.	1989	—
*	K842616	Spacelabs Alpha PC Patient Computer Summary page 2 …™ Multi Parameter Monitor: Model MPM is equivalent to: Camino, Direct Pressure Monitor, Model V420, K893232 SpaceLabs, Patient Monitor, Model Alpha PC Patient Computer, K842616. 4. DEVICE DESCRIPTION: The Intracranial Pressure-Temperature Monitoring System consists of a catheter and monitor. The cathete…	Spacelabs, Inc.	1984	2

Also cleared against K853864: 2 other devices →

What descends from it? (39)

See all 39

9 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K980380	Neurotrend Multiparameter Sensor, C7004S, to Operate with Paratrend 7+ Multiparameter…	Diametrics Medical, Ltd.	1999	27
K120252	Raumedic-Icp-Temp-Monitoring-System	Raumedic AG	2012	5
K121573	Integra Camino Icp Monitor	Intrgra Lifesciences Corporation	2012	4
K121159	Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit with Intrgra Camino…	Integra Lifescience Corportation	2012	2
K102875	Camino 110-4B Olm Intracranial Pressure Mnitoring Kit; Camino 110-4G Post Craniotomy…	Integra LifeSciences Corporation	2010	2
K072379	MPS Oxiport and MPS Oxiport Plus	Innerspace, Inc.	2008	2
K003759	Aesculap Spiegelberg Brain Pressure Monitor	Aesculap, Inc.	2001	1
K101133	Sensometrics Software	Dpcom AS	2010	0
K031086	Camino Single Parameter Monitor, Model SPM-1	Integra Neurosciences	2003	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 26, 2013	Class II	Z-0602-2014	Device Design	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 and diastolic intracranial pressure…
Oct 20, 2011	Not classified	Z-0944-2012	Under Investigation by firm	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.

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 5 ancestors has a recall of any class.
Of its descendants, K980380 (Diametrics Medical, Ltd., 1999) has gone furthest, with 27 descendants of its own.
2 other devices also cite its predicate K853864.

How does its category compare?

All GWM devices

GWM Device, Monitoring, Intracranial Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GWM

1in 2025

2007high 4 (2012) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GWM

30in 2020

2007high 192 (2016) · low 30 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GWM

3in 2025

2007high 12 (2013) · low 0 (2007)2026

Class I (3 since 2007) Class II/III not classified

Adverse event reports per year · GWM

441in 2025

2007high 744 (2023) · low 104 (2010)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?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K962928 · printed Nov 4, 2026

Cite this page

510(k) Report. “K962928: Combined Intracranial Pressure-Temperature Sensing System (Icp/).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962928

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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