# K990375: Disposable Monopolar Needle Electrode, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75

- Pathway: 510(k) (Special)
- Applicant: Medtronic Functional Diagnostics A/S
- Decided: Mar 9, 1999 after 29 days
- Product code: IKT (Electrode, Needle, Diagnostic Electromyograph)
- Device class: 2
- Regulation: 21 CFR 890.1385
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K915741 (1992). 1 ancestor in all.
6 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915741: Disposable Monoplar Meddle Electrodes, Dantec Medical, Inc. (1992) Summary page 1.

## Most influential descendants
- K072276: Subdermal Needle Electrodes (2008), 5 descendants of its own
- K130136: Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal Needle Electrodes, (2013), 3 descendants of its own
- K241045: Disposable Subdermal Needle Electrode, Corkscrew (2024), 0 descendants of its own
- K232581: Medical Disposable Sterile Needle Electrode (2023), 0 descendants of its own
- K161566: DMS Disposable Subdermal Needle Electrodes (2016), 0 descendants of its own

## Indications for use
The Disposable Monopolar Needles Electrodes are used for recording unit potentials in skeletal muscles, spontaneous activity, interference patterns and conduction velocity studies.

Source page: https://510kreport.com/device/K990375
Methodology: https://510kreport.com/methodology