# K160290: Valleylab REM Polyhesive Infant Patient Return Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: May 19, 2016 after 106 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: 2 generations back to K813072 (1981). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994428: E7512 Premie Rem Polyhesive II Patient Return Electrode, Valleylab, Inc. (2000) Summary page 4.

## Indications for use
The REM Polyhesive Infant Patient Return Electrode is a single use, non-sterile dispersive electrode with a preattached cord. The electrode adheres to the patient over its entire surface. Its purpose is to complete the electrosurgical circuit between the generator, the active electrode, and the patient. The product is used for general monopoloar electrosurgery on newborns, infants, and children weighing between approximately 6 and 30 lb.

Source page: https://510kreport.com/device/K160290
Methodology: https://510kreport.com/methodology