# K021077: Mega 2000 Soft Patient Return Electrode Pad

- Pathway: 510(k) (Traditional)
- Applicant: Megadyne Medical Products, Inc.
- Decided: Apr 17, 2002 after 14 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K822572 (1982). 4 ancestors in all.
6 later devices descend from it; 2 cite it directly.
6 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982826: MEGA 2000, Megadyne Medical Products, Inc. (1998) Summary page 1.
- K801694: Flotation Pad for Operating Table, Action Products, Inc. (1980) Summary page 1.

## Most influential descendants
- K031285: Mega 2000 Soft Dual Cord Patient Return Electrode Pad (2003), 5 descendants of its own
- K080741: Mega Soft Reusable Patient Return Electrode (2008), 4 descendants of its own
- 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

## Recalls of this device
- Jun 17, 2024 · Class I · Z-2249-2024: 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.
- Jun 1, 2023 · Class I · Z-1995-2023: Firm has received reports of patient burns in surgical procedures where device was used.

## Indications for use
The Mega 2000 Soft Patient Return Electrode Pad is to be used as a general purpose return electrode and/or a pressure reduction pad in any surgical application. Electrosurgical use is restricted to use with isolated monopolar electrosurgical generators.

Source page: https://510kreport.com/device/K021077
Methodology: https://510kreport.com/methodology