# K242346: Grass® MR Conditional/CT Cup Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Natus Manufacturing Limited
- Decided: Aug 29, 2024 after 22 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: 4 generations back to K942921 (1995). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172503: MR Conditional Cup Electrode, MR Conditional Webb Electrode, Rhythmlink International, LLC (2017) Summary page 5.

## Most influential descendants
- 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) (2026), 0 descendants of its own
- K254183: MR Conditional Cup Electrodes (2026), 0 descendants of its own

## Indications for use
The Grass MR Conditional/CT Cup Electrodes and Arrays are intended for use in the recording of the Electroencephalogram (EEG), the evoked potential (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. Intended Patient Population:2 Years and Older.

Source page: https://510kreport.com/device/K242346
Methodology: https://510kreport.com/methodology