# K080741: Mega Soft Reusable Patient Return Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Megadyne Medical Products, Inc.
- Decided: Dec 16, 2008 after 274 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 3 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K822572 (1982). 15 ancestors in all.
4 later devices descend from it; 1 cites it directly.
6 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021077: Mega 2000 Soft Patient Return Electrode Pad, Megadyne Medical Products, Inc. (2002) Summary page 2.
- K031285: Mega 2000 Soft Dual Cord Patient Return Electrode Pad, Megadyne Medical Products, Inc. (2003) Summary page 2.
- K994428: E7512 Premie Rem Polyhesive II Patient Return Electrode, Valleylab, Inc. (2000) Summary page 2.
- K063161: Skintact Cool Contact Electrosurgical Grounding Plate with NH 04 Gel, Leonhard Lang GmbH (2006) Summary page 2.

## Most influential descendants
- K133726: Mega Soft Universal Patient Return Electrode (2014), 3 descendants of its own
- K233644: Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848) (2024), 0 descendants of its own
- K210727: HotDog Warming Mattress + Return Electrode (2022), 0 descendants of its own
- K183148: OKLand Patient Return Electrode Pad (2020), 0 descendants of its own

## Recalls of this device
- Jun 17, 2024 · Class I · Z-2248-2024: To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.
- May 8, 2024 · Class I · Z-1920-2024: Reports of patient burns.
- Jun 1, 2023 · Class I · Z-1997-2023: Firm has received reports of patient burns in surgical procedures where device was used.

## Indications for use
This device is designed to be used whenever monopolar electrosurgy is indicated. The intended use of this device is to conduct monopolar electrosurgical energy from target tissue of a patient back to one or two electrosurgical units (ESU), or generators. At the same time the product reduces the risk of pressure related injury due to immobility during surgery. Electrosurgical use is restricted to use with isolated monopolar electrosurgical generators. The device is not intended for RF ablation.

Source page: https://510kreport.com/device/K080741
Methodology: https://510kreport.com/methodology