# K090180: Tender-Trode Prewired Pediatric Ecg Electrode

- Pathway: 510(k) (Abbreviated)
- Applicant: Vermed, Inc.
- Decided: Jun 17, 2009 after 145 days
- Product code: DRX (Electrode, Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K911529 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911529: Bunny Electrode/Stealth Electrode Pre Wired Eeg, Lead-Lok, Inc. (1992) Summary page 1.

## Indications for use
The Tender-Trode® Prewired electrode is a disposable, noninvasive electrode that is intended to be used for resting ECG monitoring on neonatal and pediatric patients in a hospital setting. These electrodes can be used for short-term or long-term applications, up to 24 hours. The Tender-Trode® prewired electrodes are single-use, non-sterile, disposable and are to be used on intact (uninjured) skin.

Source page: https://510kreport.com/device/K090180
Methodology: https://510kreport.com/methodology