Cleared Special

K020728 - MIETHKE SHUNT SYSTEM

K020728 is an FDA 510(k) clearance for MIETHKE SHUNT SYSTEM, manufactured by Aesculap, Inc.. The device is a Class 2 Neurology device with product code HCA cleared through the Special 510(k) pathway after a 30-day FDA review.

K020728 · Aesculap, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
30d
Days
Class 2
Risk

K020728 is an FDA 510(k) clearance for the MIETHKE SHUNT SYSTEM. Classified as Catheter, Ventricular (product code HCA), Class II - Special Controls.

Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on April 5, 2002 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4100 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Aesculap, Inc. devices

FDA 510(k) Submission Details - K020728

510(k) Number K020728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2002
Decision Date April 05, 2002
Days to Decision 30 days
Submission Type Special
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
118d faster than avg
Panel avg: 148d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

HCA Device Classification - Class 2, Special Controls

Product Code HCA Catheter, Ventricular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4100
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 - HCA Catheter, Ventricular

All 7
Devices cleared under the same product code (HCA) and FDA review panel - the closest regulatory comparables to K020728.
Cleveland Multiport Ventricular Catheter Set
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K992796 · Image-Guided Neurologics, Inc. · Oct 1999
MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102
K983331 · Medtronic PS Medical · Dec 1998