510(k) Report

510(k) · Cleared

Cleared

Ventricular Pressure Monitoring Kit, Model 110-4HM

K914735510(k) TraditionalCleared Jan 17, 199288-day reviewClass II21 CFR 882.1620

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

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

Cleared on Jan 17, 1992 after an 88-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 40 later devices descend from it.

Decided
Jan 17, 1992
Review
88 days
Class
Class II
Product code
GWM
Recalls
None
Predicates
0

40 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared2012: 4 descendants cleared2013: 2 descendants cleared2014: 1 descendant cleared2008: 3 descendants cleared2003: 1 descendant cleared2010: 3 descendants cleared1999: 1 descendant cleared2001: 1 descendant cleared2016: 2 descendants cleared2009: 1 descendant cleared2017: 3 descendants cleared2025: 2 descendants cleared2002: 1 descendant cleared2005: 1 descendant cleared2006: 2 descendants cleared2026: 2 descendants cleared2011: 1 descendant cleared2020: 2 descendants cleared2019: 2 descendants cleared2018: 1 descendant cleared2022: 1 descendant cleared2015: 1 descendant cleared2024: 1 descendant cleared1990200020102020
  1. This deviceK914735 Ventricular Pressure Monitoring Kit, Model 110-4HMCamino Laboratories, Inc. · 1992
  2. Descendant · cites it directly · 39 of its ownK962928 Combined Intracranial Pressure-Temperature Sensing System (Icp/)Camino Neurocare, Inc. · 1996 · Recalled
  3. Descendant · 2 generations on · 27 of its ownK980380 Neurotrend Multiparameter Sensor, C7004S, to Operate with Paratrend…Diametrics Medical, Ltd. · 1999
  4. Descendant · 3 generations on · 17 of its ownK050702 Neurosystems 1TM MonitorNeurosystems, LLC · 2005
  5. Descendant · 4 generations on · 15 of its ownK061640 Integra Mobius Multi-Modality Monitoring SystemIntegra LifeSciences Corporation · 2006
  6. Descendant · 5 generations on · 14 of its ownK080217 Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · Recalled

Showing 5 of 40 descendants. See all descendants

Descendants cleared per year

1996: 11999: 12001: 12002: 12003: 12005: 12006: 22008: 32009: 12010: 32011: 12012: 42013: 22014: 12015: 12016: 22017: 32018: 12019: 22020: 22022: 12024: 12025: 22026: 2
1996high 4 (2012) · low 0 (1997)2026

Most influential descendants

Showing 5 of 40 · 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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K914735Ventricular Pressure Monitoring Kit, Model 110-4HMCamino Laboratories, Inc.1992—
+1K962928Combined Intracranial Pressure-Temperature Sensing System (Icp/)Camino Neurocare, Inc.19962
+2K980380Neurotrend Multiparameter Sensor, C7004S, to Operate with Paratrend 7+…Diametrics Medical, Ltd.1999—
+3K050702Neurosystems 1TM MonitorNeurosystems, LLC2005—
+4K061640Integra Mobius Multi-Modality Monitoring SystemIntegra LifeSciences Corporation2006—
+5K080217Component Neuromonitoring SystemMoberg Research, Inc.20081

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199910
200110
200210
200310
200510
200620
200830
200910
201030
201110
201240
201320
201410
201510
201620
201730
201810
201920
202020
202210
202410
202520
202620
FIG. 1 — Lineage of K914735, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K252241 Pressio 3 Multi-parameter Neuromonitoring Systemscore 13.0 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (40)

See all 40

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

NumberDeviceApplicantDecidedDescendants
K962928Combined Intracranial Pressure-Temperature Sensing System (Icp/)Camino Neurocare, Inc.199639
K121159Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit with Intrgra Camino…Integra Lifescience Corportation20122

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 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

2007: 22008: 22009: 12010: 22011: 32012: 42013: 22014: 22016: 32017: 32018: 12019: 22020: 32021: 22024: 22025: 12026 (partial year): 1
2007high 4 (2012) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GWM

30in 2020

2011: 123 days median2012: 100 days median2016: 192 days median2017: 37 days median2020: 30 days median
2007high 192 (2016) · low 30 (2020)2026

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

Recalls per year · GWM

3in 2025

2008: 12010: 92011: 62012: 12013: 122014: 22019: 12023: 1, 1 Class I2024: 4, 2 Class I2025: 3
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

2007: 1262008: 1052009: 1172010: 1042011: 1842012: 1512013: 1202014: 3602015: 4862016: 4192017: 4452018: 3022019: 2602020: 2682021: 2112022: 4242023: 7442024: 6412025: 441
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—0126
20082—1105
20091—0117
20102—9104
201131236184
201241001151
20132—12120
20142—2360
20150—0486
201631920419
20173370445
20181—0302
20192—1260
20203300268
20212—0211
20220—0424
20230—1 (1)744
20242—4 (2)641
20251—3441
20261—0—

More from Camino Laboratories, Inc.

18 FDA decisions under this applicant name. See the company

  • K932769Camino Ventricular Drainage SystemCamino Laboratories, Inc. · 1995
  • K930222Camino Ventricular Access DeviceCamino Laboratories, Inc. · 1993
  • K930221Camino Ventricular Transducer AccessoryCamino Laboratories, Inc. · 1993
  • K920088Camino Ventricular NeedleCamino Laboratories, Inc. · 1992
  • K912833Camino Model M420: Monit Inter W/Mean Pres DisplayCamino Laboratories, Inc. · 1991

Recent decisions in GWM

The GWM category page

  • K252241Pressio 3 Multi-parameter Neuromonitoring SystemSophysa · 2026
  • K250285Neurovent-P (092946-003); Neurovent (092956-003); Neurovent-Ifd-R (095317-003); Neurovent-Ifd-S…Raumedic AG · 2025
  • K240821B4C System - Addition of new sensor model (BcSs-PICNIW-2000)Braincare Desenvolvimento E Inovação Tecnológica S.A. · 2024
  • K232890CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)Integra Lifesciences Production Corporation · 20241 Class I recall
  • K201989B4C SystemBraincare Desenvolvimento E Inovacao Tecnologica S.A. · 2021

https://510kreport.com/device/K914735 · printed Nov 4, 2026

Cite this page

510(k) Report. “K914735: Ventricular Pressure Monitoring Kit, Model 110-4HM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K914735

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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