# K121268: Wandy Dispersvie Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Med USA, Inc.
- Decided: Dec 20, 2012 after 238 days
- Product code: ODR (Electrosurgical Patient Return Electrode)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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 K954633 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100686: Conmed Macrolyte Dispersive Electrode, Conmed Corporation (2010) Summary page 1.

## Indications for use
Wandy's Dispersive Electrode is intended use to the patient during Electrosurgical procedures to provide a path for RF current to leave the patient and return to the Generator

Source page: https://510kreport.com/device/K121268
Methodology: https://510kreport.com/methodology