# K142803: Skintact, various other tradenames

- Pathway: 510(k) (Traditional)
- Applicant: Leonhard Lang GmbH
- Decided: Dec 2, 2014 after 64 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K955628 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072233: Skintact Multifunctional Electrodes with DH02 Gel with Different Connectors Compatible with Different Defibrillators, Leonhard Lang GmbH (2007) Summary page 4.
- K082090: 9131 Defibrillation Electrodes, Cardiac Science Corporation (2008) Summary page 4.

## Recalls of this device
- Aug 8, 2017 · Class I · Z-3109-2017: Certain lots of the defibrillation electrodes model DF59N and DF59NC may have a delay in connecting or not connect at all with the defibrillator ZOLL AED PLUS. This may cause a situation in which a pa
- Sep 1, 2016 · Class I · Z-0004-2017: There is a risk that defibrillation electrodes model DF29N will be connected with the defibrillator Welch Allyn AED 10 only with delay or not at all. This may cause a situation in which a patient, who

## Indications for use
Skintact® Multifunction Electrodes are for use on adults and children weighing more than 25 kg for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and single use only.

Source page: https://510kreport.com/device/K142803
Methodology: https://510kreport.com/methodology