Cleared Traditional

K020285 - CMA CEREBRAL TISSUE MONITORING SYSTEM

K020285 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 Traditional 510(k) pathway after a 268-day FDA review.

K020285 · Cma Microdialysis AB · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
268d
Days
Class 2
Risk

K020285 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 Attleboro, US). The FDA issued a Cleared decision on October 23, 2002 after a review of 268 days - an extended review 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: 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 Cma Microdialysis AB devices

FDA 510(k) Submission Details - K020285

510(k) Number K020285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2002
Decision Date October 23, 2002
Days to Decision 268 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
120d slower than avg
Panel avg: 148d · This submission: 268d
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 47
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K020285.
INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM
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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
CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS
K992591 · Codman & Shurtleff, Inc. · Oct 1999