# K040249: Skintact Ecg Electrode

- Pathway: 510(k) (Special)
- Applicant: Leonhard Lang GmbH
- Decided: Feb 24, 2004 after 21 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 K930312 (1993). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971444: 3M Red Dot 2234 & 2266 Radiolucent Monitoring Electrodes, 3M Medical Products Group (1997) Summary page 1.
- K991105: Ecg Electrode (Various), Conmedcorp (1999) Summary page 1.
- (no number) Skintact® ECG Electrodes: named in the summary without a submission number

## Most influential descendants
- K073104: Skintact and Various Other Tradenames (2007), 2 descendants of its own
- 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 radiolucent and MRI-compatible 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 radiolucent and MRI-compatible ECG electrodes are single use, non-sterile and disposable and are to be used on intact (uninjured) skin.

Source page: https://510kreport.com/device/K040249
Methodology: https://510kreport.com/methodology