# K972269: Disposable Patient Return Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Erbe USA, Inc.
- Decided: Jul 9, 1997 after 22 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.
21 later devices descend from it; 2 cite it directly.
3 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K030362: Skintact Cool Contact Electrosurgical Grounding Plates (2003), 19 descendants of its own
- K063161: Skintact Cool Contact Electrosurgical Grounding Plate with NH 04 Gel (2006), 14 descendants of its own
- K140500: Skintact (2014), 4 descendants of its own
- K080741: Mega Soft Reusable Patient Return Electrode (2008), 4 descendants of its own
- K173877: BOWA Neutral Electrodes (2018), 3 descendants of its own

## Indications for use
ERBE Disposable Patient Return Electrodes are Indicated for Use only in conjunction with Electrosurgical Generators for cutting and coagulation of human tissue. The Electrodes are for use with Generators with Return Electrode Safety Systems (divided contact surface) and Generators without Return Electrode Safety Systems (single contact surface). The Electrodes must be applied as close as possible to the operative site, preferably on the thigh or upper arm of the patient, and must not be applied to scars, infected skin, bony protrusions, or over metal implants.

Source page: https://510kreport.com/device/K972269
Methodology: https://510kreport.com/methodology