# K000079: Nikopad Electrosurgical Grounding Pad, Model 4777M

- Pathway: 510(k) (Special)
- Applicant: Nikomed U.S.A., Inc.
- Decided: Feb 4, 2000 after 24 days
- Product code: HAM (Apparatus, Electrosurgical)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
801 later devices descend from it; 3 cite it directly.
0 of 802 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
- K013639: Thermage Thermacool TC System (2002), 799 descendants of its own
- K021402: Thermage Thermacool TC System (2002), 789 descendants of its own
- K030142: Thermacool TC System (2003), 773 descendants of its own
- K031671: Polaris WR (2003), 678 descendants of its own
- K033942: Thermage Thermacool System (2004), 527 descendants of its own

## Recalls of this device
- Jul 16, 2003 · Not classified · Z-1122-03: Pads may have a thin plastic film covering the conductive gel surface underneath the normal printed cover, causing non-adherence and possible burn.
- Jul 16, 2003 · Not classified · Z-1121-03: Pads may have a thin plastic film covering the conductive gel surface underneath the normal printed cover, causing non-adherence and possible burn.

Source page: https://510kreport.com/device/K000079
Methodology: https://510kreport.com/methodology