Cleared Traditional

K042558 - EQUI-FLOW VALVE AND SHUNT SYSTEM

K042558 is an FDA 510(k) clearance for EQUI-FLOW VALVE AND SHUNT SYSTEM, manufactured by Integra Neurosciences Implants S.A.. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K042558 · Integra Neurosciences Implants S.A. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
15d
Days
Class 2
Risk

K042558 is an FDA 510(k) clearance for the EQUI-FLOW VALVE AND SHUNT SYSTEM. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Integra Neurosciences Implants S.A. (Planisboro, US). The FDA issued a Cleared decision on October 6, 2004 after a review of 15 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 Integra Neurosciences Implants S.A. devices

FDA 510(k) Submission Details - K042558

510(k) Number K042558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2004
Decision Date October 06, 2004
Days to Decision 15 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
133d faster than avg
Panel avg: 148d · This submission: 15d
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 204
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K042558.
MEDTRONIC STRATAVARIUS
K041992 · Medtronic Neurosurgery · Jan 2005
ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM
K042825 · Integra LifeSciences Corporation · Dec 2004
PS MEDICAL STRATA II VALVE
K042465 · Medtronic Neurosurgery · Oct 2004
PS MEDICAL NEUROSURGICAL IMPLANTS
K042198 · Medtronic Neurosurgery · Sep 2004
MEDTRONIC PS MEDICAL STRATA VALVE
K040943 · Medtronic Neurosurgery · Jun 2004
MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SI
K041296 · Codman & Shurtleff, Inc. · Jun 2004