Cleared Special

K242034 - Duet External Drainage and Monitoring System (EDMS) (FDA 510(k) Clearance)

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K242034 · Medtronic Neurosurgery · Neurology device
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Oct 2024
Decision
105d
Days
Class 2
Risk

K242034 is an FDA 510(k) clearance for the Duet External Drainage and Monitoring System (EDMS). Classified as External Cerebrospinal Fluid (csf) Diversion (product code PCB), Class II - Special Controls.

Submitted by Medtronic Neurosurgery (Fort Worth, US). The FDA issued a Cleared decision on October 24, 2024 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5560 - 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. Standard predicate reliance. 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 Neurosurgery devices

Submission Details

510(k) Number K242034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2024
Decision Date October 24, 2024
Days to Decision 105 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
43d faster than avg
Panel avg: 148d · This submission: 105d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code PCB External Cerebrospinal Fluid (csf) Diversion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5560
Definition Cerebrospinal Fluid (csf) Diversion Intended To Alter Spinal Cord Perfusion.
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.