# K020468: Chin Electrode

- Pathway: 510(k) (Abbreviated)
- Applicant: Dymedix, Inc.
- Decided: Apr 16, 2002 after 63 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 K931430 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931430: Cutaneous Electrode, Medicotest, Inc. (1993) Summary page 1.

## Indications for use
The DYmedix Inc. Chin Electrode is a cutaneous electromyography (EMG) electrode. The Chin Electrode supports EMG monitoring of muscles in the chin and other surface EMG monitoring locations as directed by a physician during sleep studies.

Source page: https://510kreport.com/device/K020468
Methodology: https://510kreport.com/methodology