Cleared Traditional

K042825 - ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM

K042825 is an FDA 510(k) clearance for ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM, manufactured by Integra LifeSciences Corporation. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K042825 · Integra LifeSciences Corporation · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
70d
Days
Class 2
Risk

K042825 is an FDA 510(k) clearance for the ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Integra LifeSciences Corporation (Planisboro, US). The FDA issued a Cleared decision on December 21, 2004 after a review of 70 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 LifeSciences Corporation devices

FDA 510(k) Submission Details - K042825

510(k) Number K042825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2004
Decision Date December 21, 2004
Days to Decision 70 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
78d faster than avg
Panel avg: 148d · This submission: 70d
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 220
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K042825.
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MEDTRONIC STRATAVARIUS
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POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400
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K042359 · Medical Designs, LLC · Nov 2004
PS MEDICAL STRATA II VALVE
K042465 · Medtronic Neurosurgery · Oct 2004