# K071080: Electrosurgical Infant Patient Return Electrode, Dual Plate with Cord, Model EP 211M

- Pathway: 510(k) (Traditional)
- Applicant: E Surgical, LLC
- Decided: Aug 31, 2007 after 136 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
Longest line of descent: 1 generation back to K060255 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060255: E Surgical Electrosurgical Patient Return Electrode, Dual Plate with Cord and Electrosurgical Patient Return Electrode, E Surgical, LLC (2006) Summary page 1.

## Indications for use
A Single use, non-sterile dispersive electrode with a pre-attached cord used to adhere to the Infant patient over the entire pad surface to complete the electrosurgical circuit between the generator, the active electrode, and the patient.

Source page: https://510kreport.com/device/K071080
Methodology: https://510kreport.com/methodology