# K024247: Skintact Ecg Electrodes with KL 02 Liquid Gel

- Pathway: 510(k) (Special)
- Applicant: Leonhard Lang GmbH
- Decided: Jan 16, 2003 after 24 days
- Product code: DRX (Electrode, Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2360
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K982521 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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.

## Recalls of this device
- Nov 2, 2015 · Class II · Z-0292-2016: There is a risk ECG electrodes of specific lots fail to transmit signals. There is a risk that the affected electrodes will transmit a poor signal or no signal at all before reaching the indicated exp
- Feb 24, 2015 · Class II · Z-1350-2015: The electrodes may fail to transmit signals.

## 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/K024247
Methodology: https://510kreport.com/methodology