# K073104: Skintact and Various Other Tradenames

- Pathway: 510(k) (Special)
- Applicant: Leonhard Lang GmbH
- Decided: Nov 16, 2007 after 14 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: 3 generations back to K930312 (1993). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023503: Skintact Ecg Electrode, Leonhard Lang GmbH (2002) Summary page 1.
- K040249: Skintact Ecg Electrode, Leonhard Lang GmbH (2004) Summary page 1.
- K000690: 3M Red Dot Radiolucent Monitoring Electrode with Conductive Adhesive, Minnesota Mining and Mfg. Co. (2000) Summary page 1.
- K000206: Pals Neonatal Pediatric Ecg Electrode, Models PN100, PN200, Axelgaard Mfg. Co., Ltd. (2000) Summary page 1.

## Most influential descendants
- K090496: Qwiklead Reusable Electrocardiograph Electrode Patch (2009), 0 descendants of its own
- K080106: Skintact Pre-Wired Ecg Electrodes with Conductive Adhesive (2008), 0 descendants of its own

## 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/K073104
Methodology: https://510kreport.com/methodology