# K984276: Disposable Electrosurgery Grounding Pad

- Pathway: 510(k) (Traditional)
- Applicant: E & M Engineering, Inc.
- Decided: Feb 10, 1999 after 72 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This grounding pad, also know as dispersive, neutral, or return electrode, is applied to the patient’s skin during surgery to reliably conduct the required surgical R.F. current with minimal rise in skin temperature, thereby reducing the risk of electrosurgical effect or burns to the patient. This device is used when electrosurgery generators and pencils with electodes are needed during a surgical procedure. The dispersive electrode is large in area, compared to the active electrode on pencil, thus promoting low current density so burns to the patient do not happen. The electosugical generator produces (radio frequency) R.F. current to high-density electrode known as the active electrode. The dispersive electrode reduces the current to low density and returns the current back to the generator. Again reducing the risk for burns to the skin of the patient. The grounding pad is coupled to the patient usually by direct contact with the skin, and may be used with semi-liquid or conductive gel. This is usually done with the disposable grounding pad.

Source page: https://510kreport.com/device/K984276
Methodology: https://510kreport.com/methodology