Cleared Traditional

K822864 - INTRACRANIAL PRESSURE MONITORING DEVICE

K822864 is an FDA 510(k) clearance for INTRACRANIAL PRESSURE MONITORING DEVICE, manufactured by Medex, Inc.. The device is a Class 2 Neurology device with product code GWM cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K822864 · Medex, Inc. · Neurology device
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Nov 1982
Decision
50d
Days
Class 2
Risk

K822864 is an FDA 510(k) clearance for the INTRACRANIAL PRESSURE MONITORING DEVICE. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Medex, Inc. (Walker, US). The FDA issued a Cleared decision on November 16, 1982 after a review of 50 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 Medex, Inc. devices

FDA 510(k) Submission Details - K822864

510(k) Number K822864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1982
Decision Date November 16, 1982
Days to Decision 50 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 148d · This submission: 50d
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 66
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K822864.
INTRACRANIAL PRESSURE MONITORING KIT 070
K853864 · Camino Laboratories, Inc. · Feb 1986
INTRACRANIAL PRESSURE MONITORING CUP CATHETERS
K854657 · Cordis Corp. · Dec 1985
DISPOSABLE ICP KIT DIFF. SIZES
K840003 · Codman & Shurtleff, Inc. · Feb 1984
TM-5 INTRACRANIAL PRESSURE MONITOR
K802149 · Nicolet Biomedical Instruments · Nov 1980
CHEEK EPIDURAL SCREW
K802137 · Codman & Shurtleff, Inc. · Oct 1980
CHEEK TOOL SET
K802138 · Codman & Shurtleff, Inc. · Oct 1980