# K072276: Subdermal Needle Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Xian Friendship Electronics Co., Ltd.
- Decided: May 16, 2008 after 275 days
- Product code: GXZ (Electrode, Needle)
- Device class: 2
- Regulation: 21 CFR 882.1350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K870795 (1987). 24 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050194: Axon Systems Subdermal Needle Electrodes, Axon Systems, Inc. (2005) Summary page 1.
- K022914: Rhythmlink International Subdermal Needle Electrodes, Rhythmlink International, LLC (2002) Summary page 1.
- K990375: Disposable Monopolar Needle Electrode, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75, Medtronic Functional Diagnostics A/S (1999) Summary page 2.

## Most influential descendants
- 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
- K152984: Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes (2016), 0 descendants of its own

## Indications for use
Subdermal Needle Electrodes are intended for use with recording, monitoring and stimulation/recording equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals and for stimulation during the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction. The electrodes are sterile and for single patient use only.

Source page: https://510kreport.com/device/K072276
Methodology: https://510kreport.com/methodology