# K093825: Ambu Neuroline Disposable Inoject Needle Electrode

- Pathway: 510(k) (Special)
- Applicant: Ambu A/S
- Decided: Jan 13, 2010 after 30 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 K973444 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071185: Modification to: Ambu Neuroline, Disposable Monopolar Needle Electrode, Ambu A/S (2007) Summary page 1.
- K001869: Diagnostic Electromyography Needle Electrode, Disposable Hypodermic Needle, Medicotest A/S (2000) Summary page 1.
- K973444: Teca Myoject Disposable Needle Electrodes, Medelec, Inc. D.B.A. Teca Corp. (1997) Summary page 1.
- K002992: Disposable Hypodermic Needle Electrode, Model 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431, Medtronic Functional Diagnostics A/S (2001) Summary page 1.

## Indications for use
Electromyography (EMG) Needle Electrode designed for Botulinum Toxin therapy. and nerve block procedures. For single patient use only.

Source page: https://510kreport.com/device/K093825
Methodology: https://510kreport.com/methodology