# K091410: Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot,

- Pathway: 510(k) (Traditional)
- Applicant: Spes Medica Srl
- Decided: Aug 11, 2009 after 90 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: 2 generations back to K973444 (1997). 11 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973529: Neuroline, Disposable Concentric Needle Electrodes, Medicotest A/S (1997) Summary page 1.
- K983597: Neuroline, Disposable Monopolar Needle Electrodes, Medicotest, Inc. (1999) Summary page 1.
- K001869: Diagnostic Electromyography Needle Electrode, Disposable Hypodermic Needle, Medicotest A/S (2000) Summary page 1.
- K071186: Modification to: Ambu Neuroline Concentric Needle Electrode, Ambu A/S (2007) Summary page 1.
- K071185: Modification to: Ambu Neuroline, Disposable Monopolar Needle Electrode, Ambu A/S (2007) Summary page 1.
- K961013: Disposable Needle Electrode, Medelec Intl. Corp. (1996) Summary page 1.
- K973442: Teca Disposable Monopolar Needle Electrodes, Medelec, Inc. D.B.A. Teca Corp. (1997) Summary page 1.
- K973444: Teca Myoject Disposable Needle Electrodes, Medelec, Inc. D.B.A. Teca Corp. (1997) Summary page 1.
- K931966: Dantec Disposable Concentric Needle, Dantec Medical, Inc. (1994) Summary page 1.
- K062437: Disposable Hypodermic Emg Needle Electrode Technomed Europe Version and Private Labeled, Technomed Europe (2007) Summary page 1.

## Most influential descendants
- K092973: Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar Needle (2010), 1 descendant 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
Recording muscle activity for Electromyography (EMG) applications. For single patient use only. The disposable hypodermic needle is inteded to be used for injection of the Botulinum Toxin into a muscle, while recording electromyography activity. The electrode has an open lumen and is designed for muscle stimulation, motor unit action, potential recording and Botulinum Toxin injection.

Source page: https://510kreport.com/device/K091410
Methodology: https://510kreport.com/methodology