# K092291: Skintact and Various Other Tradenames

- Pathway: 510(k) (Special)
- Applicant: Leonhard Lang GmbH
- Decided: Aug 21, 2009 after 23 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 K960968 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030509: Skintact Ecg Tab Electrode, Leonhard Lang GmbH (2003) 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/K092291
Methodology: https://510kreport.com/methodology