# K140500: Skintact

- Pathway: 510(k) (Traditional)
- Applicant: Leonhard Lang GmbH
- Decided: Jul 29, 2014 after 152 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K853291 (1985). 9 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063161: Skintact Cool Contact Electrosurgical Grounding Plate with NH 04 Gel, Leonhard Lang GmbH (2006) Summary page 1.
- K030362: Skintact Cool Contact Electrosurgical Grounding Plates, Leonhard Lang GmbH (2003) Summary page 1.
- K994428: E7512 Premie Rem Polyhesive II Patient Return Electrode, Valleylab, Inc. (2000) Summary page 1.

## Most influential descendants
- K173877: BOWA Neutral Electrodes (2018), 3 descendants of its own
- K203494: Nissha Medical Technologies Neutral Electrodes (2021), 1 descendant of its own
- K242204: Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I, GP202M-A, GP202M-P, GP202M-I, GP202B-AC, GP202B-PC, GP202B-IC, GP202M-AC, GP202M-PC, GP202M-IC, GP203M-A, GP203B-A, GP203M-AC, GP203B-AC, GP203M-P, GP203B-P, GP203M-PC, GP203B-PC, GP203M-I, GP203B-I, GP203M-IC, GP203B-IC) (2024), 0 descendants of its own
- K231985: Disposable Grounding Pad (2024), 0 descendants of its own

## Indications for use
Skintat Neutral Electrodes for Neonates are designed for use with electrosurgical generators for culling and coagulation of human tissue of newborn or prematurely born patients of between approximately I and 11 lbs (0.45 kg and 4.99 kg).

Source page: https://510kreport.com/device/K140500
Methodology: https://510kreport.com/methodology