# K051529: Ambu Neuroline Ground

- Pathway: 510(k) (Traditional)
- Applicant: Ambu, Inc.
- Decided: Aug 4, 2005 after 56 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Viasys Healthcare / Nicolet Biomedical Instruments Disposable Ground Plate Electrode: named in the summary without a submission number
- (no number) Oxford Instruments Medical / Medelec Instruments TECA NCS 2000 Disposable Ground Electrode: named in the summary without a submission number

## Indications for use
The intended use of Ambu Neuroline Ground electrode is to ensure the presence of the same electrical potential at the amplifier and the measuring point during a neurophysiological examination of muscles and/or nerves. The electrode is for single patient use only.

Source page: https://510kreport.com/device/K051529
Methodology: https://510kreport.com/methodology