# K000870: KM-10 Tens Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Katecho, Inc.
- Decided: Nov 7, 2000 after 232 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K073532: Disposable Adhesive Surface Electrodes, Disc Electrodes (2008), 2 descendants of its own
- K211839: Electrode Market Disposable Surface Electrodes (2021), 0 descendants of its own
- K180247: DAEHAN Adhesive Surface Electrodes (2018), 0 descendants of its own
- K081279: Pro-Tech Delivery System Electrodes, Model TT-2000 (2009), 0 descendants of its own

Source page: https://510kreport.com/device/K000870
Methodology: https://510kreport.com/methodology