# K900997: K-Sterile Tens Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Katecho, Inc.
- Decided: Mar 13, 1990 after 11 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K130816: Interx Sterile Self-Adhesive Dual Electrode (Issde) (2013), 0 descendants of its own

Source page: https://510kreport.com/device/K900997
Methodology: https://510kreport.com/methodology