Cleared Traditional

K131184 - INTEGRA LICOX PTO2 MONITOR

K131184 is an FDA 510(k) clearance for INTEGRA LICOX PTO2 MONITOR, manufactured by Integra Lifesciences Corp.. The device is a Class 2 Neurology device with product code GWM cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K131184 · Integra Lifesciences Corp. · Neurology device
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Aug 2013
Decision
127d
Days
Class 2
Risk

K131184 is an FDA 510(k) clearance for the INTEGRA LICOX PTO2 MONITOR. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Integra Lifesciences Corp. (Burlington, US). The FDA issued a Cleared decision on August 30, 2013 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1620 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Integra Lifesciences Corp. devices

FDA 510(k) Submission Details - K131184

510(k) Number K131184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2013
Decision Date August 30, 2013
Days to Decision 127 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 148d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWM Device Classification - Class 2, Special Controls

Product Code GWM Device, Monitoring, Intracranial Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GWM Device, Monitoring, Intracranial Pressure

All 66
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K131184.
QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT
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RAUMEDIC-PTO-MONITORING-SYSTEM
K130529 · Raumedic AG · Oct 2013
INTEGRA CAMINO ICP MONITOR
K121573 · Intrgra Lifesciences Corporation · Sep 2012
INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER
K121159 · Integra Lifescience Corportation · Jul 2012
HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)
K113088 · Innerspace, Inc. · May 2012