Cleared Traditional

K932429 - CORDIS GRAVITY COMPENSATING ACCESSORY

K932429 is an FDA 510(k) clearance for CORDIS GRAVITY COMPENSATING ACCESSORY, manufactured by Cordis Corp.. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 426-day FDA review.

K932429 · Cordis Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
426d
Days
Class 2
Risk

K932429 is an FDA 510(k) clearance for the CORDIS GRAVITY COMPENSATING ACCESSORY. 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 July 20, 1994 after a review of 426 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Cordis Corp. devices

FDA 510(k) Submission Details - K932429

510(k) Number K932429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1993
Decision Date July 20, 1994
Days to Decision 426 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
278d slower than avg
Panel avg: 148d · This submission: 426d
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 177
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K932429.
CORDIS HORIZONTAL-VERICAL VALVE SYSTEM
K944595 · Cordis Corp. · Oct 1995
PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT
K951258 · Pudenz-Schulte Medical Research Corp. · Sep 1995
CODMAN-MEDOS VALVE SHUNT SYSTEM
K944222 · Johnson & Johnson Professionals, Inc. · Jul 1995
PS MEDICAL DELTA BURR HOLE VALVE
K934545 · Pudenz-Schulte Medical Research Corp. · Apr 1994
CORDIS POLYPROPYLENE BURR HOLE RESERVOIR
K925810 · Cordis Corp. · Mar 1994
VENTRI-CATH
K931989 · Gesco Intl., Inc. · Jul 1993