# K010431: Lead-Lok Reusable Tens/ Nmes Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Lead-Lok, Inc.
- Decided: Sep 6, 2001 after 205 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
32 later devices descend from it; 4 cite it directly.
0 of 33 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
- K052875: Prostim Reusable Neurostimulation Electrodes (2005), 22 descendants of its own
- K062675: Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap Series and Double Side Series (2007), 21 descendants of its own
- K083302: Lifecare Electrodes (2009), 14 descendants of its own
- K130987: Valutrode Neurostimlation Electrodes (2013), 10 descendants of its own
- K070807: Cutaneous Electrotherapy and Recording Electrodes; Tens Electrodes (2007), 6 descendants of its own

Source page: https://510kreport.com/device/K010431
Methodology: https://510kreport.com/methodology