# K092973: Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar Needle

- Pathway: 510(k) (Traditional)
- Applicant: Bionen S.A.S.
- Decided: Oct 7, 2010 after 377 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: 4 generations back to K870795 (1987). 30 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071186: Modification to: Ambu Neuroline Concentric Needle Electrode, Ambu A/S (2007) Summary page 1.
- K931966: Dantec Disposable Concentric Needle, Dantec Medical, Inc. (1994) Summary page 1.
- K050194: Axon Systems Subdermal Needle Electrodes, Axon Systems, Inc. (2005) Summary page 1.
- K091410: Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot,, Spes Medica Srl (2009) Summary page 7.
- K062437: Disposable Hypodermic Emg Needle Electrode Technomed Europe Version and Private Labeled, Technomed Europe (2007) Summary page 7.

## Most influential descendants
- 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
The BIONEN Disposable Concentric Needle electrodes are sterile electrodes indicated for recording muscle activity for Electro-myography (EMG) applications. The electrodes are for single patient use only. The BIONEN Disposable Monopolar/Subdermal Needle electrodes are sterile electrodes indicated for recording muscle activity for Electro-myography (EMG) and/or Electroencephalography (EEG) applications. The electrodes are for single patient use only. The BIONEN Disposable Monopolar Needle electrodes are sterile electrodes indicated for injection of Botulinum Toxin while recording muscle activity with Electroymyography (EMG) applications. The electrodes are for single patient use only.

Source page: https://510kreport.com/device/K092973
Methodology: https://510kreport.com/methodology