Cleared Traditional

K042359 - SUBDURAL EVACUATING PORT SYSTEM CRANIAL...

K042359 is the FDA 510(k) clearance for SUBDURAL EVACUATING PORT SYSTEM CRANIAL... by Medical Designs, LLC. It is a Class 2 Neurology device (product code JXG) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K042359 · Medical Designs, LLC · Neurology device
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Nov 2004
Decision
78d
Days
Class 2
Risk

K042359 is an FDA 510(k) clearance for the SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SE.... Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Medical Designs, LLC (Sioux Falls, US). The FDA issued a Cleared decision on November 17, 2004 after a review of 78 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 Medical Designs, LLC devices

Submission Details

510(k) Number K042359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2004
Decision Date November 17, 2004
Days to Decision 78 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
70d faster than avg
Panel avg: 148d · This submission: 78d
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 157
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K042359.
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K031303 · Aesculap, Inc. · Jun 2003
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K030698 · Aesculap, Inc. · Mar 2003