# K915741: Disposable Monoplar Meddle Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Dantec Medical, Inc.
- Decided: Dec 8, 1992 after 354 days
- Product code: GXE (Leukotome)
- Device class: 1
- Regulation: 21 CFR 882.4600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K990375: Disposable Monopolar Needle Electrode, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75 (1999), 6 descendants of its own
- 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

Source page: https://510kreport.com/device/K915741
Methodology: https://510kreport.com/methodology