510(k) Report

510(k) · Cleared

Cleared

Model V420 Direct Pressure Monitor & 427 Waveform

K893232510(k) TraditionalCleared Jul 14, 198977-day reviewClass II21 CFR 870.1110

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

Camino Laboratories, Inc. · DSK Computer, Blood-Pressure

Cleared on Jul 14, 1989 after a 77-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 40 later devices descend from it.

Decided
Jul 14, 1989
Review
77 days
Class
Class II
Product code
DSK
Recalls
None
Predicates
0

40 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared2008: 3 descendants cleared2003: 1 descendant cleared2012: 4 descendants cleared2010: 3 descendants cleared1999: 1 descendant cleared2001: 1 descendant cleared2016: 2 descendants cleared2009: 1 descendant cleared2017: 3 descendants cleared2025: 2 descendants cleared2013: 2 descendants cleared2014: 1 descendant 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 deviceK893232 Model V420 Direct Pressure Monitor & 427 WaveformCamino Laboratories, Inc. · 1989
  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)K893232Model V420 Direct Pressure Monitor & 427 WaveformCamino Laboratories, Inc.1989—
+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 K893232, 1989–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 DSK? 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 DSK device

  1. #1 K231586 Endophys Blood Pressure Monitor model BPM-30score 8.7 · 9 generations · no Class I recall
Get a 510(k) 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? (40)

See all 40

1 later device cites 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

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 DSK devices

DSK Computer, Blood-Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DSK

1in 2023

2007: 12008: 12015: 22016: 12023: 1
2007high 2 (2015) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSK

Too few DSK 510(k)s in any year since 2007 to give a median.

Recalls per year · DSK

No recall names DSK since 2007.

Adverse event reports per year · DSK

26in 2025

2010: 102011: 52012: 692013: 52014: 82015: 72016: 132017: 62018: 932019: 1482020: 292021: 312022: 292023: 142024: 122025: 26
2007high 148 (2019) · low 0 (2007)2025

MAUDE reports naming product code DSK, 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
20071—00
20081—00
20090—00
20100—010
20110—05
20120—069
20130—05
20140—08
20152—07
20161—013
20170—06
20180—093
20190—0148
20200—029
20210—031
20220—029
20231—014
20240—012
20250—026
20260—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
  • K914735Ventricular Pressure Monitoring Kit, Model 110-4HMCamino Laboratories, Inc. · 1992

Recent decisions in DSK

The DSK category page

  • K231586Endophys Blood Pressure Monitor model BPM-30Endophys Technologies, LLC · 2023
  • K160945Endophys Blood Pressure MonitorEndophys Holdings, LLC · 2016
  • K152582CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter BoxVolcano Corporation · 2015
  • K141615Endophys Blood Pressure MonitorEndophys, Inc. · 2015
  • K080670Modification to Sphygmocor Cardiovascular Management SystemAtcor Medical · 2008

https://510kreport.com/device/K893232 · printed Nov 3, 2026

Cite this page

510(k) Report. “K893232: Model V420 Direct Pressure Monitor & 427 Waveform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K893232

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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