Cleared Traditional

OPTYX (K904883) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 73
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K904883.
ORBIS-SIGMA VALVE SYSTEM FOR VENTRICULAR SHUNTING
K913636 · Cordis Corp. · Dec 1991
RIGHT-ANGLE CATHETER FOR VENTRICULAR DRAINAGE
K911433 · Cordis Corp. · Sep 1991
HEYER-SCHULTE SPINAL CYST CATHETER/MODIFICATION
K905860 · Baxter Healthcare Corp · Sep 1991
GRADUATED CYLINDER OF EXTERNAL DRAINAGE SET
K910853 · Cordis Corp. · Apr 1991
OMNISHUNT SYSTEM FOR VENTRICULAR SHUNTING
K903844 · Cordis Corp. · Dec 1990
THE PUDENZ IN LINE VALVE
K894072 · Baxter Healthcare Corp · Aug 1989