# K023920: Skintact

- Pathway: 510(k) (Traditional)
- Applicant: Leonhard Lang GmbH
- Decided: Jan 16, 2003 after 52 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: 2 generations back to K960968 (1996). 3 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 9 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.
- K982521: Skintact Ecg Electrodes, S&W Ecg Electrodes, Leonhard Lang Co. (1999) Summary page 1.
- (no number) Tracet Ag 4000 electrodes by LecTec Corporation: named in the summary without a submission number

## Most influential descendants
- K030509: Skintact Ecg Tab Electrode (2003), 4 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
- K090496: Qwiklead Reusable Electrocardiograph Electrode Patch (2009), 0 descendants of its own
- K092291: Skintact and Various Other Tradenames (2009), 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/K023920
Methodology: https://510kreport.com/methodology