# K061148: Rhythmlink Disc Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Rhythmlink International, LLC
- Decided: May 10, 2006 after 15 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: 1 generation back to K942921 (1995). 2 ancestors in all.
50 later devices descend from it; 6 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942921: Neurolink Eeg/EP/Emg Surface Electrodes, Neuro Supplies, Inc. (1995) Summary page 1.
- K991772: Cutaneous (Disc) Electrode, Neuro Supplies, Inc. (1999) Summary page 1.

## Most influential descendants
- K112718: Nuvasive NVM5 System (2012), 35 descendants of its own
- K123307: Nuvasive NVM5 System (2013), 33 descendants of its own
- K132694: Nuvasive NVM5 System (2014), 24 descendants of its own
- K141968: Nuvasive NVM5 System (2014), 23 descendants of its own
- K143641: NuVasive NVM5 System (2015), 22 descendants of its own

## Indications for use
The Rhythmlink Disc Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials.

Source page: https://510kreport.com/device/K061148
Methodology: https://510kreport.com/methodology