# K260578: Ambu® NeurolineTM Cup MRI/CT  (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set  (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set  (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)

- Pathway: 510(k) (Traditional)
- Applicant: Ambu A/S
- Decided: Jul 14, 2026 after 144 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
Longest line of descent: 5 generations back to K942921 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242346: Grass® MR Conditional/CT Cup Electrodes, Natus Manufacturing Limited (2024) Summary page 5.

## Indications for use
The Ambu® Neuroline™ Cup MRI/CT is intended to obtain and transmit electroencephalography (EEG) or evoked potential (EP) signals to the compatible Ambu harness, from where the signals can be transmitted to a monitoring and recording device. The Ambu® Neuroline™ Cup MRI/CT is intended to be disconnected from all harness cables and left in place on the patient during Magnetic Resonance (MR) imaging and Computerized Tomography (CT) scanning. The Ambu® Neuroline™ Cup MRI/CT is indicated when there is a need for neurophysiological examination of the brain. The Ambu® Neuroline™ Cup MRI/CT can be used for adults and pediatrics (from 2 years and older).

Source page: https://510kreport.com/device/K260578
Methodology: https://510kreport.com/methodology