# K080106: Skintact Pre-Wired Ecg Electrodes with Conductive Adhesive

- Pathway: 510(k) (Special)
- Applicant: Leonhard Lang GmbH
- Decided: Feb 1, 2008 after 17 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: 4 generations back to K930312 (1993). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073104: Skintact and Various Other Tradenames, Leonhard Lang GmbH (2007) Summary page 1.
- K000206: Pals Neonatal Pediatric Ecg Electrode, Models PN100, PN200, Axelgaard Mfg. Co., Ltd. (2000) Summary page 1.
- K053011: Pro-Neo Neonatal Ecg Electrode, Models SG15 and SR20, Bio Protech, Inc. (2005) Summary page 1.
- K053550: Ambu Blue Sensor Neo and Neo X, Ambu A/S (2006) Summary page 1.

## Indications for use
Skintact ECG Electrodes are designed for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician. Such procedures include in particular patient ECG surveillance and ECG diagnosis recording. Skintact ECG Electrodes are single use, non-sterile and disposable and are to be used on intact (uninjured) skin.

Source page: https://510kreport.com/device/K080106
Methodology: https://510kreport.com/methodology