510(k) · Cleared
ClearedIntracranial Pressure Monitoring Kit 070
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Camino Laboratories, Inc. · GWM Device, Monitoring, Intracranial Pressure
Cleared on Feb 20, 1986 after a 156-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 42 later devices descend from it.
- Decided
- Feb 20, 1986
- Review
- 156 days
- Class
- Class II
- Product code
- GWM
- Recalls
- None
- Predicates
- 0
42 later devices descend from it, 3 citing it directly.
- This deviceK853864 Intracranial Pressure Monitoring Kit 070Camino Laboratories, Inc. · 1986
- Descendant · cites it directly · 39 of its ownK962928 Combined Intracranial Pressure-Temperature Sensing System (Icp/)Camino Neurocare, Inc. · 1996 · Recalled
- Descendant · 2 generations on · 27 of its ownK980380 Neurotrend Multiparameter Sensor, C7004S, to Operate with Paratrend…Diametrics Medical, Ltd. · 1999
- Descendant · 3 generations on · 17 of its ownK050702 Neurosystems 1TM MonitorNeurosystems, LLC · 2005
- Descendant · 4 generations on · 15 of its ownK061640 Integra Mobius Multi-Modality Monitoring SystemIntegra LifeSciences Corporation · 2006
- Descendant · 5 generations on · 14 of its ownK080217 Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · Recalled
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 42 · See all- K962928Combined Intracranial Pressure-Temperature Sensing System (Icp/)Camino Neurocare, Inc. · 1996 · cites it directly39descendants
- K980380Neurotrend Multiparameter Sensor, C7004S, to Operate with Paratrend 7+ Multiparameter…Diametrics Medical, Ltd. · 1999 · 2 generations on27descendants
- K050702Neurosystems 1TM MonitorNeurosystems, LLC · 2005 · 3 generations on17descendants
- K061640Integra Mobius Multi-Modality Monitoring SystemIntegra LifeSciences Corporation · 2006 · 4 generations on15descendants
- K080217Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · 5 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K853864 | Intracranial Pressure Monitoring Kit 070 | Camino Laboratories, Inc. | 1986 | — |
| +1 | K962928 | Combined Intracranial Pressure-Temperature Sensing System (Icp/) | Camino Neurocare, Inc. | 1996 | 2 |
| +2 | K980380 | Neurotrend Multiparameter Sensor, C7004S, to Operate with Paratrend 7+… | Diametrics Medical, Ltd. | 1999 | — |
| +3 | K050702 | Neurosystems 1TM Monitor | Neurosystems, LLC | 2005 | — |
| +4 | K061640 | Integra Mobius Multi-Modality Monitoring System | Integra LifeSciences Corporation | 2006 | — |
| +5 | K080217 | Component Neuromonitoring System | Moberg Research, Inc. | 2008 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (42)
See all 423 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K962928 (Camino Neurocare, Inc., 1996) has gone furthest, with 39 descendants of its own.
How does its category compare?
All GWM devicesGWM Device, Monitoring, Intracranial Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K853864 · printed Nov 4, 2026
Cite this page
510(k) Report. “K853864: Intracranial Pressure Monitoring Kit 070.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K853864
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026