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Licox Pmo Brain Monitoring System

by Integra Lifesciences Corporation

510(k) K040235

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

12 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK040235 Date20 Apr 2004ClearedStatusActive

Recalls

12 recalls · FDA

    • Terminated Z-0831-2015 FDA Class II initiated 7 Nov 2014

    Due 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.

  • 9 recalls, same reason

    • Terminated Z-0061-2014 FDA Class II initiated 11 Jun 2013
    • Terminated Z-0056-2014 FDA Class II initiated 11 Jun 2013
    • Terminated Z-0062-2014 FDA Class II initiated 11 Jun 2013
    • Terminated Z-0063-2014 FDA Class II initiated 11 Jun 2013
    • Terminated Z-0060-2014 FDA Class II initiated 11 Jun 2013
    • Terminated Z-0057-2014 FDA Class II initiated 11 Jun 2013
    • Terminated Z-0055-2014 FDA Class II initiated 11 Jun 2013
    • Terminated Z-0054-2014 FDA Class II initiated 11 Jun 2013
    • Terminated Z-0059-2014 FDA Class II initiated 11 Jun 2013

    Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.

    • Terminated Z-0161-2011 FDA Unclassified (pre-2012) initiated 15 Sep 2010

    Incorrect expiration date - The outer boxes of the IP2P Licox Complete Kit for Cerebral Pressure, Temperature and ICP Monitoring Probes, Lot 250210A are labeled with an incorrect shelf life date (10 months too long).

    • Terminated Z-1422-2010 FDA Unclassified (pre-2012) initiated 18 Feb 2010

    One probe that had failed a product release test was inadvertently packaged and released into inventory in Integra's distribution center.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GWM
Device Class
Class II
Regulation
21 CFR Part 882.1620
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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