# K242204: Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I, GP202M-A, GP202M-P, GP202M-I, GP202B-AC, GP202B-PC, GP202B-IC, GP202M-AC, GP202M-PC, GP202M-IC, GP203M-A, GP203B-A, GP203M-AC, GP203B-AC, GP203M-P, GP203B-P, GP203M-PC, GP203B-PC, GP203M-I, GP203B-I, GP203M-IC, GP203B-IC)

- Pathway: 510(k) (Traditional)
- Applicant: Dongguan Quanding Medical Supplies Co., Ltd.
- Decided: Sep 25, 2024 after 61 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: 7 generations back to K853291 (1985). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203494: Nissha Medical Technologies Neutral Electrodes, Nissha Medical Technologies, Ltd. (2021) Summary page 6.

## Indications for use
Disposable neutral electrodes are indicated for use to adhere to the patient over the entire pad surface to complete an electrical circuit during electrosurgery between the electrosurgical generator, the active electrode and the patient. Solid Electrosurgical pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split Electrosurgical pads are for use with generators that have a CQMS (i.e. REM,ARM,NESSY etc.).

Source page: https://510kreport.com/device/K242204
Methodology: https://510kreport.com/methodology