Cleared Traditional

K801755 - MMI/GAELTEC CATHETER TIP PRESSURE

K801755 is the FDA 510(k) clearance for MMI/GAELTEC CATHETER TIP PRESSURE by Medical Measurements, Inc.. It is a Class 2 Neurology device (product code GWM) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K801755 · Medical Measurements, Inc. · Neurology device
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Aug 1980
Decision
16d
Days
Class 2
Risk

K801755 is an FDA 510(k) clearance for the MMI/GAELTEC CATHETER TIP PRESSURE. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Medical Measurements, Inc. (Nutley, US). The FDA issued a Cleared decision on August 13, 1980 after a review of 16 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 Medical Measurements, Inc. devices

Submission Details

510(k) Number K801755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1980
Decision Date August 13, 1980
Days to Decision 16 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
132d faster than avg
Panel avg: 148d · This submission: 16d
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 35
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K801755.
DISPOSABLE ICP KIT DIFF. SIZES
K840003 · Codman & Shurtleff, Inc. · Feb 1984
CHEEK EPIDURAL SCREW
K802137 · Codman & Shurtleff, Inc. · Oct 1980
CHEEK TOOL SET
K802138 · Codman & Shurtleff, Inc. · Oct 1980
INTRACRANIAL PRESSURE MONITORING
K790920 · Codman & Shurtleff, Inc. · Aug 1979
CATHETER, INTRACRANIAL PRESS. MONITOR.
K772063 · Cordis Corp. · Jan 1978