Cleared Special

K200456 - Becker External Drainage and Monitoring...

K200456 is the FDA 510(k) clearance for Becker External Drainage and Monitoring... by Medtronic, Inc.. It is a Class 2 Neurology device (product code GWM) cleared through the Special 510(k) pathway after a 30-day FDA review.

K200456 · Medtronic, Inc. · Neurology device
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Mar 2020
Decision
30d
Days
Class 2
Risk

K200456 is an FDA 510(k) clearance for the Becker External Drainage and Monitoring System. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Medtronic, Inc. (Goleta, US). The FDA issued a Cleared decision on March 26, 2020 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1620 - 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 Medtronic, Inc. devices

Submission Details

510(k) Number K200456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2020
Decision Date March 26, 2020
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.

Device Classification

Product Code GWM Device, Monitoring, Intracranial Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1620
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 - GWM Device, Monitoring, Intracranial Pressure

All 37
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K200456.
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K172209 · Branchpoint Technologies, Inc. · May 2018