Cleared Traditional

K802100 - INTRACRANIAL PRESSURING MONITORING SYST. (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K802100 · Pudenz-Schulte Medical Research Corp. · Neurology device
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Sep 1980
Decision
13d
Days
Class 2
Risk

K802100 is an FDA 510(k) clearance for the INTRACRANIAL PRESSURING MONITORING SYST.. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Pudenz-Schulte Medical Research Corp. (Mchenry, US). The FDA issued a Cleared decision on September 16, 1980 after a review of 13 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 Pudenz-Schulte Medical Research Corp. devices

Submission Details

510(k) Number K802100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1980
Decision Date September 16, 1980
Days to Decision 13 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
135d faster than avg
Panel avg: 148d · This submission: 13d
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.

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