# K081371: Skintact Pediatric Multifunction Electrodes with DH03 Gel

- Pathway: 510(k) (Traditional)
- Applicant: Leonhard Lang GmbH
- Decided: Sep 24, 2008 after 132 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 1 (1 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). 4 ancestors in all.
No later device cites it as a predicate yet.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992977: Hewlett Packard Multifunction Pediatric Defib Function, Model M3503A & M3504A, Hewlett-Packard Co. (1999) Summary page 1.
- K072233: Skintact Multifunctional Electrodes with DH02 Gel with Different Connectors Compatible with Different Defibrillators, Leonhard Lang GmbH (2007) Summary page 1.

## Recalls of this device
- Dec 3, 2014 · Class I · Z-0802-2015: The firm discovered that during the use of these defibrillation electrodes a possibility for arcing and a resulting malfunction exists. This could lead to a situation, in which a patient who is in a l

## Indications for use
Skintact® Pediatric Multifunction Electrodes are for use on pediatric patients, less than 8 years of age, or weighing less than 25 kg (55 lbs), for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and for single use only. These electrodes have been qualified for use with defibrillators delivering a maximum of 100 joules such as: Zoll M and E series and PD1200, 1400, 1600 & 1700 defibrillators; Medtronic LifePak 9, 10, 12 and 20 defibrillators; Philips Heartstart MRx and XL defibrillators; Welch Allyn PIC 30, PIC 40 and PIC 50 defibrillators; Philips Codemaster XE, XL, XL+ and 100 defibrillators.

Source page: https://510kreport.com/device/K081371
Methodology: https://510kreport.com/methodology