Cleared Traditional

OMNISHUNT SYSTEM FOR VENTRICULAR SHUNTING (K903844) - FDA 510(k) Clearance

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

K903844 · Cordis Corp. · Neurology device
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Dec 1990
Decision
129d
Days
Class 2
Risk

K903844 is an FDA 510(k) clearance for the OMNISHUNT SYSTEM FOR VENTRICULAR SHUNTING. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Cordis Corp. (Miami, US). The FDA issued a Cleared decision on December 28, 1990 after a review of 129 days - within the typical 510(k) review window.

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 Cordis Corp. devices

Submission Details

510(k) Number K903844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1990
Decision Date December 28, 1990
Days to Decision 129 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
19d faster than avg
Panel avg: 148d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 94
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K903844.
CODMAN EXTERNAL DRAINAGE SYSTEM II (EDS II)
K910938 · Codman & Shurtleff, Inc. · Aug 1991
OPTYX
K904883 · Baxter Healthcare Corp · Jul 1991
GRADUATED CYLINDER OF EXTERNAL DRAINAGE SET
K910853 · Cordis Corp. · Apr 1991
ACCU-FLO* UNITIZED SHUNT
K904120 · Codman & Shurtleff, Inc. · Oct 1990
CODMAN* EXTERNAL DRAINAGE SYSTEM II (EDS-II)
K902257 · Codman & Shurtleff, Inc. · Jul 1990
UNI-SHUNT(TM) WITH ELLIPTICAL RESERVOIR KIT
K892215 · Codman & Shurtleff, Inc. · Aug 1989