Cleared Traditional

GRADUATED CYLINDER OF EXTERNAL DRAINAGE SET (K910853) - FDA 510(k) Clearance

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

K910853 · Cordis Corp. · Neurology device
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Apr 1991
Decision
55d
Days
Class 2
Risk

K910853 is an FDA 510(k) clearance for the GRADUATED CYLINDER OF EXTERNAL DRAINAGE SET. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Cordis Corp. (Miami Lakes, US). The FDA issued a Cleared decision on April 24, 1991 after a review of 55 days - a notably fast clearance 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: 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

Submission Details

510(k) Number K910853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1991
Decision Date April 24, 1991
Days to Decision 55 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
93d faster than avg
Panel avg: 148d · This submission: 55d
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 K910853.
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
OPTYX
K904883 · Baxter Healthcare Corp · Jul 1991
OMNISHUNT SYSTEM FOR VENTRICULAR SHUNTING
K903844 · Cordis Corp. · Dec 1990
ACCU-FLO* UNITIZED SHUNT
K904120 · Codman & Shurtleff, Inc. · Oct 1990
CODMAN* EXTERNAL DRAINAGE SYSTEM II (EDS-II)
K902257 · Codman & Shurtleff, Inc. · Jul 1990