# K972273: TBD

- Pathway: 510(k) (Traditional)
- Applicant: Megadyne Medical Products, Inc.
- Decided: Jul 8, 1997 after 20 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: 1 generation back to K822572 (1982). 1 ancestor in all.
8 later devices descend from it; 1 cites it directly.
6 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K822572: Polyhesive Patient Return Electrode, Valleylab, Inc. (1982) Summary page 1.

## Most influential descendants
- K982826: MEGA 2000 (1998), 7 descendants of its own
- K021077: Mega 2000 Soft Patient Return Electrode Pad (2002), 6 descendants of its own
- 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

## Indications for use
The MegaDyne reusable patient return electrode is to be used as a general purpose return electrode in any electrosurgical application in which a standard monopolar electrosurgical generator is used.

Source page: https://510kreport.com/device/K972273
Methodology: https://510kreport.com/methodology