Cleared Traditional

K802149 - TM-5 INTRACRANIAL PRESSURE MONITOR

K802149 is the FDA 510(k) clearance for TM-5 INTRACRANIAL PRESSURE MONITOR by Nicolet Biomedical Instruments. It is a Class 2 Neurology device (product code GWM) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K802149 · Nicolet Biomedical Instruments · Neurology device
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Nov 1980
Decision
65d
Days
Class 2
Risk

K802149 is an FDA 510(k) clearance for the TM-5 INTRACRANIAL PRESSURE MONITOR. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Nicolet Biomedical Instruments (Mchenry, US). The FDA issued a Cleared decision on November 12, 1980 after a review of 65 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 Nicolet Biomedical Instruments devices

Submission Details

510(k) Number K802149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1980
Decision Date November 12, 1980
Days to Decision 65 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 148d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 38
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K802149.
INTRACRANIAL PRESSURE MONITORING CUP CATHETERS
K854657 · Cordis Corp. · Dec 1985
DISPOSABLE ICP KIT DIFF. SIZES
K840003 · Codman & Shurtleff, Inc. · Feb 1984
INTRACRANIAL PRESSURE MONITORING DEVICE
K822864 · Medex, Inc. · Nov 1982
CHEEK EPIDURAL SCREW
K802137 · Codman & Shurtleff, Inc. · Oct 1980
CHEEK TOOL SET
K802138 · Codman & Shurtleff, Inc. · Oct 1980
INTRACRANIAL PRESSURING MONITORING SYST.
K802100 · Pudenz-Schulte Medical Research Corp. · Sep 1980