Cleared Traditional

HEYER-SCHULTE SPINAL CYST CATHETER/MODIFICATION (K905860) - FDA 510(k) Clearance

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

K905860 · Baxter Healthcare Corp · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1991
Decision
263d
Days
Class 2
Risk

K905860 is an FDA 510(k) clearance for the HEYER-SCHULTE SPINAL CYST CATHETER/MODIFICATION. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Niles, US). The FDA issued a Cleared decision on September 10, 1991 after a review of 263 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 K905860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1990
Decision Date September 10, 1991
Days to Decision 263 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
115d slower than avg
Panel avg: 148d · This submission: 263d
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 K905860.
CORDIS RIGHT-ANGLE CATHETER GUIDE
K913842 · Cordis Corp. · Feb 1992
ORBIS-SIGMA VALVE SYSTEM FOR VENTRICULAR SHUNTING
K913636 · Cordis Corp. · Dec 1991
RIGHT-ANGLE CATHETER FOR VENTRICULAR DRAINAGE
K911433 · Cordis Corp. · Sep 1991
OPTYX
K904883 · Baxter Healthcare Corp · Jul 1991
GRADUATED CYLINDER OF EXTERNAL DRAINAGE SET
K910853 · Cordis Corp. · Apr 1991
OMNISHUNT SYSTEM FOR VENTRICULAR SHUNTING
K903844 · Cordis Corp. · Dec 1990