# K130136: Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal Needle Electrodes,

- Pathway: 510(k) (Traditional)
- Applicant: Technomed Europe
- Decided: Jul 19, 2013 after 182 days
- Product code: GXZ (Electrode, Needle)
- Device class: 2
- Regulation: 21 CFR 882.1350
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K870795 (1987). 34 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990015: Electrode Needles, Technomed Europe (1999) Summary page 1.
- K050325: Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar Probe, Technomed Europe (2005) Summary page 1.
- K062437: Disposable Hypodermic Emg Needle Electrode Technomed Europe Version and Private Labeled, Technomed Europe (2007) Summary page 1.
- K112034: Teca Elite Disposable Concentric Needles, Carefusion 209, Inc. (2011) Summary page 2.
- K072276: Subdermal Needle Electrodes, Xian Friendship Electronics Co., Ltd. (2008) Summary page 1.

## Most influential descendants
- K241045: Disposable Subdermal Needle Electrode, Corkscrew (2024), 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

## Recalls of this device
- Aug 9, 2022 · Class II · Z-1737-2022: Burns of varying degrees can occur to patients with electrodes left in while in the MRI scanner as a result of inadequate safety information in the IFU.
- Dec 8, 2021 · Class II · Z-0465-2022: There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp.

## Indications for use
Needle Electrodes for Neurological purposes are intended for use with recording, monitoring equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals, and are intended for stimulation/recording with stimulation/recording equipment for electromyograph (EMG) and nerve potential signals.

Source page: https://510kreport.com/device/K130136
Methodology: https://510kreport.com/methodology