# K171102: Ives MR Conditional Cup Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Ives Egg Solutions
- Decided: Dec 21, 2017 after 252 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: 3 generations back to K942921 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071118: Gold Cup Electrode, Silver Cup Electrode and Electrode with AG-AG/CL Coating and Conductive Plastic Electrode, Ives Eeg Solutions, Inc. (2007) Summary page 4.
- K130287: MR Conditional Cup Electrode, MR Conditional Webb Electrode, Rhythmlink International, LLC (2013) Summary page 4.
- K122376: PMT Truscan Surface Electrode, Pmt Corp. (2012) Summary page 4.

## Indications for use
The Ives MR Conditional Cup Electrodes are intended for use in the general recording and monitoring of the electroencephalography (EEG), evoked potential (EP) as well as ground and reference related to the EEG and EP recording. The Cup Electrodes are intended to be left in place during MR imaging at 1.5T and 3T as well as during CT scanning. The extension cable must be disconnected from the Ives MR Conditional Cup Electrodes before scanning and MUST remain disconnected throughout the entire MR scan. EEG or EP should not be recorded throughout the entire the CT and MR imaging.

Source page: https://510kreport.com/device/K171102
Methodology: https://510kreport.com/methodology