Cleared Traditional

K890468 - MODEL FT-100 INTRACRANIAL PRESSURE MONITOR

K890468 is an FDA 510(k) clearance for MODEL FT-100 INTRACRANIAL PRESSURE MONITOR, manufactured by Pearl Instruments Corp.. The device is a Class 2 Neurology device with product code GWM cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K890468 · Pearl Instruments Corp. · Neurology device
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Apr 1989
Decision
85d
Days
Class 2
Risk

K890468 is an FDA 510(k) clearance for the MODEL FT-100 INTRACRANIAL PRESSURE MONITOR. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Pearl Instruments Corp. (Highland Park, US). The FDA issued a Cleared decision on April 26, 1989 after a review of 85 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 Pearl Instruments Corp. devices

FDA 510(k) Submission Details - K890468

510(k) Number K890468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1989
Decision Date April 26, 1989
Days to Decision 85 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 148d · This submission: 85d
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 72
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K890468.
MODEL 704
K912139 · Ivy Biomedical Systems, Inc. · Mar 1992
VENTRICULAR PRESSURE MONITORING KIT, MODEL 110-4HM
K914735 · Camino Laboratories, Inc. · Jan 1992
TRANSPAC(R) II, DISPOSABLE TRANSDUCER
K884823 · Abbott Laboratories · Jul 1990
PMT SUBARACHNOID SCREW, MODEL NO.1350-2
K883115 · Pmt Corp. · Aug 1988
VENTRICULAR BOLT PRESSURE MONITORING KIT #110-4H
K881183 · Camino Laboratories, Inc. · May 1988
CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT
K853770 · Codman & Shurtleff, Inc. · Oct 1986