# K160366: Electrosurgical disposable grounding pads

- Pathway: 510(k) (Traditional)
- Applicant: Top-Rank Health Care Co., Ltd.
- Decided: Aug 19, 2016 after 192 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: 5 generations back to K853291 (1985). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091672: Disposable Grounding Pad Series and Electrode Series, Shuyou Electric Medical Science Co., Ltd. (2009) Summary page 5.

## Indications for use
Electrosurgical disposable grounding pads are to conduct electrosurgical energy from target tissue of a patient back to an electrosurgical unit (ESU), or generator.

Source page: https://510kreport.com/device/K160366
Methodology: https://510kreport.com/methodology