Cleared Traditional

K121159 - INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K121159 · Integra Lifescience Corportation · Neurology device
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Jul 2012
Decision
95d
Days
Class 2
Risk

K121159 is an FDA 510(k) clearance for the INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INT.... Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Integra Lifescience Corportation (Planisboro, US). The FDA issued a Cleared decision on July 20, 2012 after a review of 95 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.

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Submission Details

510(k) Number K121159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2012
Decision Date July 20, 2012
Days to Decision 95 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 148d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.

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