Cleared Traditional

STANDARD/PEDIATRIC CORDIS HYDROCEPHALUS VALVES (K861377) - FDA 510(k) Clearance

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

K861377 · Cordis Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1986
Decision
66d
Days
Class 2
Risk

K861377 is an FDA 510(k) clearance for the STANDARD/PEDIATRIC CORDIS HYDROCEPHALUS VALVES. 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 June 19, 1986 after a review of 66 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 K861377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1986
Decision Date June 19, 1986
Days to Decision 66 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
82d faster than avg
Panel avg: 148d · This submission: 66d
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 K861377.
THE PUDENZ IN LINE VALVE
K894072 · Baxter Healthcare Corp · Aug 1989
HEYER-SCHULTE (CSF) VENTRI ACCESS(RESERV/ANTECHAM
K891456 · Baxter Healthcare Corp · Jun 1989
EXTERNAL VENTRICULAR & LUMBAR DRAINAGE SETS
K862513 · Cordis Corp. · Aug 1986
EVDS, EVMDS, LDS & IVMCS CENTRAL NERVOUS SYS FLUID
K855058 · Cordis Corp. · Jan 1986
EXTERNAL VENTRICULAR DRAINAGE/MONITORING/LUMBAR SE
K854474 · Cordis Corp. · Nov 1985
ACCU-FLO PRESSURE VALVE
K853215 · Codman & Shurtleff, Inc. · Sep 1985