Cleared Traditional

K854657 - INTRACRANIAL PRESSURE MONITORING CUP CA...

K854657 is an FDA 510(k) clearance for INTRACRANIAL PRESSURE MONITORING CUP CA..., manufactured by Cordis Corp.. The device is a Class 2 Neurology device with product code GWM cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K854657 · Cordis Corp. · Neurology device
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Dec 1985
Decision
37d
Days
Class 2
Risk

K854657 is an FDA 510(k) clearance for the INTRACRANIAL PRESSURE MONITORING CUP CATHETERS. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Cordis Corp. (Miami, US). The FDA issued a Cleared decision on December 27, 1985 after a review of 37 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 Cordis Corp. devices

FDA 510(k) Submission Details - K854657

510(k) Number K854657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1985
Decision Date December 27, 1985
Days to Decision 37 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 148d · This submission: 37d
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 41
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K854657.
MODEL 704
K912139 · Ivy Biomedical Systems, Inc. · Mar 1992
TRANSPAC(R) II, DISPOSABLE TRANSDUCER
K884823 · Abbott Laboratories · Jul 1990
CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT
K853770 · Codman & Shurtleff, Inc. · Oct 1986
DISPOSABLE ICP KIT DIFF. SIZES
K840003 · Codman & Shurtleff, Inc. · Feb 1984
INTRACRANIAL PRESSURE MONITORING DEVICE
K822864 · Medex, Inc. · Nov 1982
TM-5 INTRACRANIAL PRESSURE MONITOR
K802149 · Nicolet Biomedical Instruments · Nov 1980