# K123915: DE48-Plus

- Pathway: 510(k) (Traditional)
- Applicant: Grass Technologies, an Astro-Med, Inc. Product Gro
- Decided: Apr 24, 2013 after 126 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: 2 generations back to K942921 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061148: Rhythmlink Disc Electrodes, Rhythmlink International, LLC (2006) Summary page 1.
- (no number) Grass Technologies' Gold Electrodes: named in the summary without a submission number

## Indications for use
The Grass "DE-48-Plus Disposable 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/K123915
Methodology: https://510kreport.com/methodology