# K062198: Sunspots Pre-Gelled Surface Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Axon Systems, Inc.
- Decided: Dec 19, 2006 after 140 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 K821137 (1982). 2 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971914: Teca NCS Electrode System 2000, Medelec, Inc. D.B.A. Teca Corp. (1998) Summary page 1.
- K821137: Meditrace Pellet Electrode, Graphic Controls Corp. (1982) Summary page 1.

## Cited in the summary but kept off the family tree
- K931030: Surface Electrodes. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K110289: Friendship Medical Disposable Pre-Gelled AG / Agcl Surface Electrode (2011), 2 descendants of its own
- K142159: Disposable Pre-Gelled Surface Electrode (2015), 1 descendant of its own
- K081871: Universal Electrodes (2008), 1 descendant of its own
- K172703: Disposable Snap Electrode (2017), 0 descendants of its own
- K120494: Disposable Adhesive Surface Electrode (2012), 0 descendants of its own

## Indications for use
Axon Systems' Pre-gelled Surface Electrodes are intended for use with electrodiagnostic or neurological monitoring equipment for the recording of electrophysiological activity and for peripheral nerve electrical stimulation. The electrodes are non-sterile and for single patient use only.

Source page: https://510kreport.com/device/K062198
Methodology: https://510kreport.com/methodology