# K023503: Skintact Ecg Electrode

- Pathway: 510(k) (Special)
- Applicant: Leonhard Lang GmbH
- Decided: Nov 14, 2002 after 27 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 K960968 (1996). 2 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982521: Skintact Ecg Electrodes, S&W Ecg Electrodes, Leonhard Lang Co. (1999) Summary page 1.
- K960968: Medi-Trace 200, Medi-Trace 200-30, Graphic Controls Corp. (1996) Summary page 1.

## Most influential descendants
- K023920: Skintact (2003), 5 descendants of its own
- K030509: Skintact Ecg Tab Electrode (2003), 4 descendants of its own
- K073104: Skintact and Various Other Tradenames (2007), 2 descendants of its own
- K040784: Protab Ecg Tabb Electrode (2004), 1 descendant of its own
- K093327: Intco Tab Electrode (2010), 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 non-sterile and are to be used on intact (uninjured) skin.

Source page: https://510kreport.com/device/K023503
Methodology: https://510kreport.com/methodology