# K071185: Modification to: Ambu Neuroline, Disposable Monopolar Needle Electrode

- Pathway: 510(k) (Special)
- Applicant: Ambu A/S
- Decided: May 30, 2007 after 30 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
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Neuroline, Disposable Monopolar needle electrode: named in the summary without a submission number
- (no number) Medelec: Elite Disposable Concentric Needle Electrode: named in the summary without a submission number

## 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
- K093825: Ambu Neuroline Disposable Inoject Needle Electrode (2010), 0 descendants of its own
- K091056: Rhythmlink Disposable Monopolar Emg Needle, Model TFDN26032252R (2009), 0 descendants of its own

## Indications for use
The Neurlirne, Disposable Monopolar needle electrodes are made for muscle activity recording for Electromyography (EMGiG) applications. The electrodes are for single patient use only.

Source page: https://510kreport.com/device/K071185
Methodology: https://510kreport.com/methodology