Cleared Traditional

K102077 - MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM

K102077 is an FDA 510(k) clearance for MODIFICATION TO CMA CEREBRAL TISSUE MON..., 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 175-day FDA review.

K102077 · Cma Microdialysis AB · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
175d
Days
Class 2
Risk

K102077 is an FDA 510(k) clearance for the MODIFICATION TO 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 January 14, 2011 after a review of 175 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.

FDA 510(k) Submission Details - K102077

510(k) Number K102077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2010
Decision Date January 14, 2011
Days to Decision 175 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
26d slower than avg
Panel avg: 149d · This submission: 175d
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 94
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K102077.
RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM
K120252 · Raumedic AG · Apr 2012
RAUMEDIC ICP MONITORING SYSTEM
K112017 · Raumedic AG · Oct 2011
RAUMEDIC- ICP-MONITORING SYSTEM
K103206 · Raumedic AG · Mar 2011
CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT
K102875 · Integra LifeSciences Corporation · Dec 2010
SENSOMETRICS SOFTWARE
K101133 · Dpcom AS · Nov 2010
SYNERGY
K083378 · Innerspace, Inc. · Sep 2009
K102077 · MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
Download PDF FDA Summary Cma Microdialysis AB