510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Licox CMP Monitor-AC3.1, Licox Imc Oxygen Catheters-CC1,CC1.SB Luicox Imc Introducer Kits-IM,IM2,IM3,II1 Licoximc Tempe

K002765510(k) TraditionalCleared Nov 24, 200080-day reviewClass II21 CFR 882.1620Recalls 3

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

Integra Neurosciences · GWM Device, Monitoring, Intracranial Pressure

Cleared on Nov 24, 2000 after an 80-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 20 later devices descend from it. It has been recalled 3 times.

Decided
Nov 24, 2000
Review
80 days
Class
Class II
Product code
GWM
Recalls
3
Predicates
0

20 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2002: 3 descendants cleared2014: 1 descendant cleared2013: 2 descendants cleared2004: 1 descendant cleared2003: 1 descendant cleared2006: 2 descendants cleared2008: 2 descendants cleared2017: 2 descendants cleared2025: 1 descendant cleared2011: 1 descendant cleared2009: 1 descendant cleared2026: 1 descendant cleared2016: 1 descendant cleared200020052010201520202025
  1. This deviceK002765 Licox CMP Monitor-AC3.1, Licox Imc Oxygen Catheters-CC1,CC1.SB…Integra Neurosciences · 2000
  2. Descendant · cites it directly · 4 of its ownK130529 Raumedic-Pto-Monitoring-SystemRaumedic AG · 2013
  3. Descendant · cites it directly · 4 of its ownK013005 Act 11 MP Ventricular CatheterInnerspace, Inc. · 2002
  4. Descendant · cites it directly · 3 of its ownK041838 MPS (or MPS-T)Innerspace, Inc. · 2005
  5. Descendant · cites it directly · 3 of its ownK020285 Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB · 2002
  6. Descendant · cites it directly · 3 of its ownK020558 Licox CC1.G2 Brain Oxygen Catheter-MicroprobeIntegra Neurosciences · 2002

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2002: 32003: 12004: 12005: 12006: 22008: 22009: 12011: 12013: 22014: 12016: 12017: 22025: 12026: 1
2002high 3 (2002) · low 0 (2007)2026

Most influential descendants

Showing 5 of 20 · See all
  • K130529Raumedic-Pto-Monitoring-SystemRaumedic AG · 2013 · cites it directly4descendants
  • K013005Act 11 MP Ventricular CatheterInnerspace, Inc. · 2002 · cites it directly4descendants
  • K041838MPS (or MPS-T)Innerspace, Inc. · 2005 · cites it directly3descendants
  • K020285Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB · 2002 · cites it directly3descendants
  • K020558Licox CC1.G2 Brain Oxygen Catheter-MicroprobeIntegra Neurosciences · 2002 · cites it directly3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002765Licox CMP Monitor-AC3.1, Licox Imc Oxygen Catheters-CC1,CC1.SB Luicox Imc…Integra Neurosciences2000—
+1K130529Raumedic-Pto-Monitoring-SystemRaumedic AG2013—
+1K013005Act 11 MP Ventricular CatheterInnerspace, Inc.2002—
+1K041838MPS (or MPS-T)Innerspace, Inc.2005—
+1K020285Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB2002—
+1K020558Licox CC1.G2 Brain Oxygen Catheter-MicroprobeIntegra Neurosciences2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200230
200310
200410
200510
200620
200820
200910
201110
201320
201410
201610
201720
202510
202610
FIG. 1 — Lineage of K002765, 2000–2026Source: 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 12.9 · 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (20)

See all 20

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

NumberDeviceApplicantDecidedDescendants
K130529Raumedic-Pto-Monitoring-SystemRaumedic AG20134
K013005Act 11 MP Ventricular CatheterInnerspace, Inc.20024
K041838MPS (or MPS-T)Innerspace, Inc.20053
K020285Cma Cerebral Tissue Monitoring SystemCma Microdialysis AB20023
K020558Licox CC1.G2 Brain Oxygen Catheter-MicroprobeIntegra Neurosciences20023
K040235Licox Pmo Brain Monitoring SystemIntegra LifeSciences Corporation20042
K032337Hemedex Cranial Bolt Models, 3601, 3602Hemedex Incorporated20031
K141869Qflow 500 Titanium Bolt, Quad Lumen Bolt KitHemedex Incorporated20140
K131184Integra Licox PTO2 MonitorIntegra Lifesciences Corp.20130

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 7, 2014Class IIZ-0831-2015Device DesignDue to a complaint, it was determined that multiple lots of Licox catheters manufactured since October 29, 2013 contained a smart card which was programmed with an inaccurate lkN2 value.
Dec 17, 2010Not classifiedZ-1518-2011Nonconforming Material/ComponentCertain LICOX CMP Tissue Oxygen Monitors could allow for underestimation of temperature values.
Jan 21, 2005Not classifiedZ-0622-05OtherLICOX Model C8.B temperature probes manufactured by GMS mbH, an Integra company, may exhibit progen (endotoxin) levels above the FDA limit of 2.15 endotoxin units per device. Elevated endotoxin levels may result in an increased patient…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K130529 (Raumedic AG, 2013) has gone furthest, with 4 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 Integra Neurosciences

8 FDA decisions under this applicant name. See the company

  • K082250Auragen Cortical Surface ElectrodesIntegra Neurosciences · 2008
  • K050720Neurosensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit/System, Models NS-P, NS-100Integra Neurosciences · 20051 recall
  • K031086Camino Single Parameter Monitor, Model SPM-1Integra Neurosciences · 2003
  • K021989Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3Integra Neurosciences · 20022 recalls
  • K022554Monitorr Icp External CSF Drainage and Monitoring SystemIntegra Neurosciences · 20022 Class I recalls

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/K002765 · printed Nov 5, 2026

Cite this page

510(k) Report. “K002765: Licox CMP Monitor-AC3.1, Licox Imc Oxygen Catheters-CC1,CC1.SB Luicox Imc Introducer Kits-IM,IM2,IM3,II1 Licoximc Tempe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002765

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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