# K991772: Cutaneous (Disc) Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Neuro Supplies, Inc.
- Decided: Aug 18, 1999 after 86 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
No predicates in its family tree.
51 later devices descend from it; 1 cites it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K061148: Rhythmlink Disc Electrodes (2006), 50 descendants of its own
- 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

## Indications for use
Cutaneous (Disc) Electrode is intended for non-invasive use as a recording (active/reference) electrode during electromyographic (EMG) recordings.

Source page: https://510kreport.com/device/K991772
Methodology: https://510kreport.com/methodology