# K050194: Axon Systems Subdermal Needle Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Axon Systems, Inc.
- Decided: Apr 26, 2005 after 89 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: 3 generations back to K870795 (1987). 20 ancestors in all.
13 later devices descend from it; 4 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010019: Sterile Subdermal Needle Electrodes, Nicolet Biomedical, Inc. (2001) Summary page 1.
- K990015: Electrode Needles, Technomed Europe (1999) Summary page 1.
- K934779: Agram Spyral Electrode, Agram Export-Import Co. (1995) Summary page 1.

## Most influential descendants
- K073229: Nerve Monitoring Cable (2008), 5 descendants of its own
- K072276: Subdermal Needle Electrodes (2008), 5 descendants of its own
- K142438: Nerve Monitoring Cable System (2015), 4 descendants of its own
- K182617: ATEC IOM Accessory Instruments (2019), 3 descendants of its own
- K130136: Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal Needle Electrodes, (2013), 3 descendants of its own

## Indications for use
Axon Systems' 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.

Source page: https://510kreport.com/device/K050194
Methodology: https://510kreport.com/methodology