# K032278: Ambu Neuroline Single Patient Eeg/EP Cup Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Ambu, Inc.
- Decided: Mar 5, 2004 after 225 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.
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K071118: Gold Cup Electrode, Silver Cup Electrode and Electrode with AG-AG/CL Coating and Conductive Plastic Electrode (2007), 2 descendants of its own
- K122376: PMT Truscan Surface Electrode (2012), 1 descendant of its own
- K200540: BRAINSTREAM Disposable Deep Cup EEG Electrodes (2020), 0 descendants of its own
- K171102: Ives MR Conditional Cup Electrode (2017), 0 descendants of its own
- K163547: MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96 (2017), 0 descendants of its own

## Indications for use
The Single Patient EEG/EP Cup Electrode is intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals for example: Electroencephalograph (EEG) and Nerve potentials signals. The electrodes are for single patient use only.

Source page: https://510kreport.com/device/K032278
Methodology: https://510kreport.com/methodology