Cleared Traditional

K904883 - OPTYX

K904883 is an FDA 510(k) clearance for OPTYX, manufactured by Baxter Healthcare Corp. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 271-day FDA review.

K904883 · Baxter Healthcare Corp · Neurology device
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Jul 1991
Decision
271d
Days
Class 2
Risk

K904883 is an FDA 510(k) clearance for the OPTYX. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Irvine, US). The FDA issued a Cleared decision on July 24, 1991 after a review of 271 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 Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K904883

510(k) Number K904883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1990
Decision Date July 24, 1991
Days to Decision 271 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
123d slower than avg
Panel avg: 148d · This submission: 271d
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 220
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K904883.
RIGHT-ANGLE CATHETER FOR VENTRICULAR DRAINAGE
K911433 · Cordis Corp. · Sep 1991
HEYER-SCHULTE SPINAL CYST CATHETER/MODIFICATION
K905860 · Baxter Healthcare Corp · Sep 1991
CODMAN EXTERNAL DRAINAGE SYSTEM II (EDS II)
K910938 · Codman & Shurtleff, Inc. · Aug 1991
PS MEDICAL BUTTON VALVE
K911410 · Pudenz-Schulte Medical Research Corp. · Jun 1991
GRADUATED CYLINDER OF EXTERNAL DRAINAGE SET
K910853 · Cordis Corp. · Apr 1991
OMNISHUNT SYSTEM FOR VENTRICULAR SHUNTING
K903844 · Cordis Corp. · Dec 1990