Cleared Special

K060554 - CMA CEREBRAL TISSUE MONITORING SYSTEM

K060554 is an FDA 510(k) clearance for CMA CEREBRAL TISSUE MONITORING SYSTEM, manufactured by Cma Microdialysis AB. The device is a Class 2 Neurology device with product code GWM cleared through the Special 510(k) pathway after a 62-day FDA review.

K060554 · Cma Microdialysis AB · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
62d
Days
Class 2
Risk

K060554 is an FDA 510(k) clearance for the CMA CEREBRAL TISSUE MONITORING SYSTEM. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Cma Microdialysis AB (North Chelmsford, US). The FDA issued a Cleared decision on May 2, 2006 after a review of 62 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K060554

510(k) Number K060554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2006
Decision Date May 02, 2006
Days to Decision 62 days
Submission Type Special
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
87d faster than avg
Panel avg: 149d · This submission: 62d
Pathway characteristics
Modification to existing cleared device.

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 98
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K060554.
PRESSIO ICP MONITORING SYSTEM
K062584 · Sophysa SA · Jul 2007
INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM
K061640 · Integra LifeSciences Corporation · Jul 2006
LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT
K053244 · Integra Lifesciences Corp. · May 2006
NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EVALUATION AND RELIEF (CIPER) KIT
K051599 · Neurorecovery, Inc. · Jul 2005
NEUROSYSTEMS 1TM MONITOR
K050702 · Neurosystems, LLC · May 2005
NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100
K050720 · Integra Neurosciences · May 2005
K060554 · CMA CEREBRAL TISSUE MONITORING SYSTEM
Download PDF FDA Summary Cma Microdialysis AB