# K103186: Skintact Radiotransparent Multifunction Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Leonhard Lang GmbH
- Decided: Feb 8, 2011 after 102 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K955628 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
1 of 6 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 1.
- K014209: Padpro  Model 2001, 2001-S, 2001-C, 2001-Eps, Padpro, LLC (2002) Summary page 1.

## Indications for use
Skintact®R Radiotransparent Multifunction Electrodes are for use on adults and children over eight years old or 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/K103186
Methodology: https://510kreport.com/methodology