Cleared Abbreviated

K020780 - TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP

K020780 is an FDA 510(k) clearance for TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, manufactured by Medex, Inc.. The device is a Class 2 Neurology device with product code GWM cleared through the Abbreviated 510(k) pathway after a 70-day FDA review.

K020780 · Medex, Inc. · Neurology device
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May 2002
Decision
70d
Days
Class 2
Risk

K020780 is an FDA 510(k) clearance for the TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Medex, Inc. (Dublin, US). The FDA issued a Cleared decision on May 20, 2002 after a review of 70 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K020780

510(k) Number K020780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2002
Decision Date May 20, 2002
Days to Decision 70 days
Submission Type Abbreviated
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 149d · This submission: 70d
Pathway characteristics
Standards-based clearance path.

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 104
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K020780.
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K013930 · Novus Monitoring, Ltd. · Feb 2002
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K003759 · Aesculap, Inc. · Jun 2001
K020780 · TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP
Download PDF Medex, Inc.