Cleared Special

K990375 - DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25 (FDA 510(k) Clearance)

Also includes:
DMN 25 DMF 37 DMN 37 DMN 50 DMN 75

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

K990375 · Medtronic Functional Diagnostics A/S · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
29d
Days
Class 2
Risk

K990375 is an FDA 510(k) clearance for the DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25. Classified as Electrode, Needle, Diagnostic Electromyograph (product code IKT), Class II - Special Controls.

Submitted by Medtronic Functional Diagnostics A/S (Copenhagen, DK). The FDA issued a Cleared decision on March 9, 1999 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.1385 - 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 Functional Diagnostics A/S devices

Submission Details

510(k) Number K990375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1999
Decision Date March 09, 1999
Days to Decision 29 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 148d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code IKT Electrode, Needle, Diagnostic Electromyograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1385
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.