# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Megadyne Medical Products, Inc.
- Decided: Jul 12, 2024 after 242 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: 7 generations back to K822572 (1982). 17 ancestors in all.
No later device cites it as a predicate yet.
6 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133726: Mega Soft Universal Patient Return Electrode, Megadyne Medical Products, Inc. (2014) Summary page 5.

## Recalls of this device
- Dec 8, 2023 · Class I · Z-0598-2024: Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention wh
- Dec 8, 2023 · Class I · Z-0599-2024: Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention wh
- Dec 8, 2023 · Class I · Z-0600-2024: Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention wh

## Indications for use
This device is designed to be used whenever monopolar electrosurgery 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. 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/K233644
Methodology: https://510kreport.com/methodology