# K822572: Polyhesive Patient Return Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Valleylab, Inc.
- Decided: Sep 21, 1982 after 28 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
No predicates in its family tree.
9 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K972273: TBD (1997), 8 descendants of its own
- 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

Source page: https://510kreport.com/device/K822572
Methodology: https://510kreport.com/methodology