# K030697: Radionics Single Use Ground Pad (DGP-HP)

- Pathway: 510(k) (Special)
- Applicant: Radionics, Inc.
- Decided: Apr 4, 2003 after 29 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K923647 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923647: RFG-DGP Disposable Grounding Pads, Radionics, Inc. (1992) Summary page 1.
- K000079: Nikopad Electrosurgical Grounding Pad, Model 4777M, Nikomed U.S.A., Inc. (2000) Summary page 1.

## Recalls of this device
- Aug 1, 2012 · Class II · Z-2301-2012: Covidien is conducting a recall of various production lots of DGHP RFA High Power single use grounding pads and Cool-tip RFA Electrode Kits due to the potential for foil degradation on the DGP-HP sing

## Indications for use
The Radionics DGP-HP Single Use Ground Pad is to be used with the Radionics Cool-tipTM RF System.

Source page: https://510kreport.com/device/K030697
Methodology: https://510kreport.com/methodology