Cleared Traditional

K895524 - HYDROCEPHALUS SHUNT SYSTEM, LOW/MEDIUM/HIGH PRESS.

K895524 is an FDA 510(k) clearance for HYDROCEPHALUS SHUNT SYSTEM, manufactured by Theramed, Inc.. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K895524 · Theramed, Inc. · Neurology device
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Apr 1990
Decision
210d
Days
Class 2
Risk

K895524 is an FDA 510(k) clearance for the HYDROCEPHALUS SHUNT SYSTEM, LOW/MEDIUM/HIGH PRESS.. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Theramed, Inc. (Ft. Lauderdale, US). The FDA issued a Cleared decision on April 10, 1990 after a review of 210 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5550 - 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 Theramed, Inc. devices

FDA 510(k) Submission Details - K895524

510(k) Number K895524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1989
Decision Date April 10, 1990
Days to Decision 210 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 148d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXG Device Classification - Class 2, Special Controls

Product Code JXG Shunt, Central Nervous System And Components
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5550
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 - JXG Shunt, Central Nervous System And Components

All 226
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K895524.
ACCU-FLO* UNITIZED SHUNT
K904120 · Codman & Shurtleff, Inc. · Oct 1990
PS MEDICAL DELTA CSF-FLOW CONTROL VALVE
K902783 · Pudenz-Schulte Medical Research Corp. · Aug 1990
CODMAN* EXTERNAL DRAINAGE SYSTEM II (EDS-II)
K902257 · Codman & Shurtleff, Inc. · Jul 1990
CSF-FLOW CONTROL VALVE, CYLINDRICAL & SHUNT KIT
K900676 · Pudenz-Schulte Medical Research Corp. · Apr 1990
PS MEDICAL CSF-ON/OFF FLUSHING RESERVOIR
K896167 · Pudenz-Schulte Medical Research Corp. · Dec 1989
UNI-SHUNT(TM) WITH ELLIPTICAL RESERVOIR KIT
K892215 · Codman & Shurtleff, Inc. · Aug 1989