Skintact, various other tradenames— 510(k) K142803

Name: FDA 510(k) clearance K142803
Creator: U.S. Food and Drug Administration
Published: 2014-12-02

Substantially Equivalent

Leonhard Lang GmbH

FDA 510(k) clearance K142803 for Skintact, various other tradenames, Substantially Equivalent on 2014-12-02. Applicant: Leonhard Lang GmbH. Device class: 3.

Clearance details

Applicant: Leonhard Lang GmbH
Product code: Code MKJ
Device class: Class 3
Regulation: 21 CFR 870.5310
Advisory panel: Cardiovascular
Date received: 2014-09-29
Decision date: 2014-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Innsbruck, AT

Download summary PDF View on FDA.gov ↗

Recent devices under product code MKJ

view all

K143714 — Powerheart G5 AED2015-05-04
K150055 — OneStep Pediatric CPR Multi-Function Electrode2015-05-02
K150198 — CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel2015-05-02
K142709 — samaritan PAD 450P2015-03-27
K133659 — HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING2015-01-23

More clearances from Leonhard Lang GmbH

view all

K140500 — SKINTACT2014-07-29
K140340 — SKINTACT2014-05-21
K103186 — SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES2011-02-08
K092291 — SKINTACT AND VARIOUS OTHER TRADENAMES2009-08-21
K081371 — SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL2008-09-24

Adverse events under product code MKJ

product code MKJ

Death: 961
Injury: 1,070
Malfunction: 90,719
Other: 8
Total: 92,758

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K142803

K-number listed on FDA's recall record

Z-3109-2017 — Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only. Used with automated external defibrillatorsClass I·Terminated·Leonhard Lang Medizintechnik GmbH·20170808
Z-0004-2017 — Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only.Class I·Terminated·Leonhard Lang Medizintechnik GmbH·20160901

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142803.

Data sourced from openFDA. This site is unofficial and independent of the FDA.