# K254183: MR Conditional Cup Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Technomed Europe
- Decided: May 7, 2026 after 135 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072016: Cup Electrodes, Gold, Reusable, Silver, Reusable; Cup Electrodes Silver/Silver Chloride Reusable, Technomed Europe (2007) Summary page 5.
- K242346: Grass® MR Conditional/CT Cup Electrodes, Natus Manufacturing Limited (2024) Summary page 5.

## Indications for use
The MR Conditional Cup Electrodes are intended for use in the recording of the Electroencephalogram (EEG), the Evoked Potentials (EP), or as a ground and reference in an EEG or EP recording. This device is non-sterile for Single Patient Use Only and may remain on the patient in an MRI or CT environment under specific conditions.

Source page: https://510kreport.com/device/K254183
Methodology: https://510kreport.com/methodology