Cleared Traditional

ICP MONITOR MODEL 1000 (K844566) - FDA 510(k) Clearance

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

K844566 · Advanced Ultrasonic Testing & Research Corp. · Neurology device
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Aug 1985
Decision
266d
Days
Class 2
Risk

K844566 is an FDA 510(k) clearance for the ICP MONITOR MODEL 1000. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Advanced Ultrasonic Testing & Research Corp. (Winston-Salem, US). The FDA issued a Cleared decision on August 16, 1985 after a review of 266 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Advanced Ultrasonic Testing & Research Corp. devices

Submission Details

510(k) Number K844566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1984
Decision Date August 16, 1985
Days to Decision 266 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 148d · This submission: 266d
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 21
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K844566.
CORDIS DISPOSABLE ICP PRESSURE TRANSDUCER
K940648 · Cordis Corp. · Mar 1995
TRANSPAC(R) II, DISPOSABLE TRANSDUCER
K884823 · Abbott Laboratories · Jul 1990
INTRACRANIAL PRESSURE MONITORING CUP CATHETERS
K854657 · Cordis Corp. · Dec 1985
CATHETER, INTRACRANIAL PRESS. MONITOR.
K772063 · Cordis Corp. · Jan 1978