# K071186: Modification to: Ambu Neuroline Concentric Needle Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Ambu A/S
- Decided: Jul 30, 2007 after 91 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: 1 generation back to K931966 (1994). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 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.
- K961013: Disposable Needle Electrode, Medelec Intl. Corp. (1996) Summary page 1.
- K931966: Dantec Disposable Concentric Needle, Dantec Medical, Inc. (1994) Summary page 1.

## Most influential descendants
- K091410: Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot, (2009), 2 descendants of its own
- 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
The Neuroline, Disposable Concentric needle electrodes are made for muscle activity recording for Electromyography (EMG) applications. The electrodes are for single patient use only.

Source page: https://510kreport.com/device/K071186
Methodology: https://510kreport.com/methodology