Cleared Traditional

K121159 - INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER

K121159 is an FDA 510(k) clearance for INTEGRA CAMINO FLEX VENTRICULAR INTRACR..., manufactured by Integra Lifescience Corportation. The device is a Class 2 Neurology device with product code GWM cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K121159 · Integra Lifescience Corportation · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K121159

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 149d · This submission: 95d
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 90
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K121159.
RAUMEDIC-PTO-MONITORING-SYSTEM
K130529 · Raumedic AG · Oct 2013
INTEGRA LICOX PTO2 MONITOR
K131184 · Integra Lifesciences Corp. · Aug 2013
INTEGRA CAMINO ICP MONITOR
K121573 · Intrgra Lifesciences Corporation · Sep 2012
HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)
K113088 · Innerspace, Inc. · May 2012
RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM
K120252 · Raumedic AG · Apr 2012
RAUMEDIC ICP MONITORING SYSTEM
K112017 · Raumedic AG · Oct 2011
K121159 · INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER
Download PDF FDA Summary Integra Lifescience C…