# K212093: Medline Universal Grounding Pad

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Jan 14, 2022 after 192 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
Medline's Universal Grounding Pads are designed for surgical applications where monopolar electrosurgery is utilized in order to provide a safe return path for the electrosurgical current. Solid Grounding Pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split style Grounding Pads are for use with electrosurgical units (ESU) that have a CQMS (i.e. REM, ARM, NESSY etc.). Medline's Universal Grounding Pads are designed to be used on any patient where full skin contact and a suitable placement site can be obtained. There are no patient weight restrictions for use of this universal style grounding pad. Use of this product for unintended applications could lead to an unsafe condition.

Source page: https://510kreport.com/device/K212093
Methodology: https://510kreport.com/methodology