# K002227: Wandy Silicone Conductive Rubber Pad

- Pathway: 510(k) (Traditional)
- Applicant: Wandy Rubber Industrial Co., Ltd.
- Decided: Feb 2, 2001 after 193 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.
17 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K132998: Wandy Self-Adhesive Electrodes (2013), 16 descendants of its own
- K160138: Adhesive Electrodes (2016), 15 descendants of its own
- K180865: ZMI Self-Adhesive Electrodes (2018), 9 descendants of its own
- K222252: Self-adhesive Electrode (2023), 6 descendants of its own
- K223802: accufit (2023), 5 descendants of its own

Source page: https://510kreport.com/device/K002227
Methodology: https://510kreport.com/methodology