# K120476: Macrolyte Dispersive Electrode

- Pathway: 510(k) (Special)
- Applicant: Conmed Corporation
- Decided: Jun 12, 2012 after 117 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K954633 (1995). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100686: Conmed Macrolyte Dispersive Electrode, Conmed Corporation (2010) Summary page 1.

## Most influential descendants
- K132136: Single Use Grounding Pad (2013), 0 descendants of its own

## Recalls of this device
- Aug 19, 2019 · Class III · Z-2545-2019: Discrepancy between the correct expiration dates on the individual pouches inside the boxes and incorrect expiration dates on the outer boxes, where the month and day were reversed.
- May 8, 2014 · Class II · Z-1719-2014: ConMed Corporation has received complaints regarding sparking, no output and burning at the cord set connection. The complaints have been confirmed by ConMed.

## Indications for use
CONMEDO Macrolyte® Dispersive Electrodes are designed for use with electrosurgical generators during electrosurgery and provide a path for, RF energy produced at the active electrode to return to the generator. The CONMVED0 MacroyteO Dispersive Electrode is for use with all patient populations providing there is sufficient surface area to ensure full contact of the electrode with the patientfs skin.

Source page: https://510kreport.com/device/K120476
Methodology: https://510kreport.com/methodology