Cleared Traditional

K061640 - INTEGRA MOBIUS MULTI-MODALITY MONITORIN...

K061640 is the FDA 510(k) clearance for INTEGRA MOBIUS MULTI-MODALITY MONITORIN... by Integra LifeSciences Corporation. It is a Class 2 Neurology device (product code GWM) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K061640 · Integra LifeSciences Corporation · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
45d
Days
Class 2
Risk

K061640 is an FDA 510(k) clearance for the INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Integra LifeSciences Corporation (Planisboro, US). The FDA issued a Cleared decision on July 27, 2006 after a review of 45 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Integra LifeSciences Corporation devices

Submission Details

510(k) Number K061640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2006
Decision Date July 27, 2006
Days to Decision 45 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
103d faster than avg
Panel avg: 148d · This submission: 45d
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.

Regulatory Peers - GWM Device, Monitoring, Intracranial Pressure

All 37
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K061640.
INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER
K133754 · Integra LifeSciences Corporation · Mar 2014
CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT
K102875 · Integra LifeSciences Corporation · Dec 2010
MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING SYSTEM
K071505 · Integra LifeSciences Corporation · Aug 2007
LICOX PMO BRAIN MONITORING SYSTEM
K040235 · Integra LifeSciences Corporation · Apr 2004
TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP
K020780 · Medex, Inc. · May 2002
AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR
K003759 · Aesculap, Inc. · Jun 2001