510(k) · Cleared

Cleared

Skintact Radiotransparent Multifunction Electrodes

K103186510(k) TraditionalCleared Feb 8, 2011102-day reviewClass III21 CFR 870.5310

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Leonhard Lang GmbH · MKJ Automated External Defibrillators (Non-Wearable)

Cleared on Feb 8, 2011 as substantially equivalent to K072233 (Leonhard Lang GmbH, 2007) and 1 other predicate after a 102-day review. Its family tree reaches back 3 generations to 1996. 1 of the 6 devices in its family, counting itself, has a Class I recall.

Decided: Feb 8, 2011
Review: 102 days
Class: Class III
Product code: MKJ
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K955628 (1996). 5 ancestors in all. No later device cites it as a predicate yet. 1 of the 6 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 3 generations backK955628 Fore Runner External Defibrillator/Defibrillator PadsHeartstream, Inc. · 1996
2 generations backK041883 Skintact Multifunction Electrodes, Model DF 21Leonhard Lang GmbH · 2004
1 generation backK072233 Skintact Multifunctional Electrodes with DH02 Gel with Different…Leonhard Lang GmbH · 2007 · Recalled
This deviceK103186 Skintact Radiotransparent Multifunction ElectrodesLeonhard Lang GmbH · 2011

Class I recalls in this family

K014209 Padpro Model 2001, 2001-S, 2001-C, 2001-Epsdirect predicate · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K955628	Fore Runner External Defibrillator/Defibrillator Pads	Heartstream, Inc.	1996	—
−2	K041883	Skintact Multifunction Electrodes, Model DF 21	Leonhard Lang GmbH	2004	—
−1	K072233	Skintact Multifunctional Electrodes with DH02 Gel with Different Connectors…	Leonhard Lang GmbH	2007	2
0 (this device)	K103186	Skintact Radiotransparent Multifunction Electrodes	Leonhard Lang GmbH	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2002	1	1

FIG. 1 — Lineage of K103186, 1996–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K072233	Skintact Multifunctional Electrodes with DH02 Gel with Different Connectors Compatible… Summary page 1 …does not introduce new issues of safety or effectiveness and Skintact' Radiotra nspa rent Multifunction Electrodes are substantially equivalent to the predicate devices K072233 and 1(014209. Traditional 510(k): Skintact' Radiotransparent Multifunction Electrodes…	Leonhard Lang GmbH	2007	2
*	K014209	Padpro Model 2001, 2001-S, 2001-C, 2001-Eps Summary page 1 …icate devices: K(072233 Leonhard Lang Skintact Multifunction Electrodes with DHO2 Gel available with different connectors compatible with different devices K(014209 PadlPro 2001, 2001-S, 2001-C, 2001-EPS Multifunction Electrodes Description of device: All Skintact* Multifunction Electrodes ar…	Padpro, LLC	2002	Class I

Also cleared against K072233: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K014209Padpro Model 2001, 2001-S, 2001-C, 2001-EpsPadpro, LLC · 2002 · Direct predicate · ◆ in the 2002 ancestors bar of FIG. 13 Class I recalls

What does this lineage say?

The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
2 of the 5 ancestors have a recall of any class; 1 has a Class I recall.
2 other devices also cite its predicate K072233.

How does its category compare?

All MKJ devices

MKJ Automated External Defibrillators (Non-Wearable): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · MKJ

48in 2025

2007high 52 (2020) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MKJ

156in 2015

2007high 250 (2010) · low 36 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MKJ

1in 2025

2007high 37 (2009) · low 1 (2015)2026

Class I (23 since 2007) Class II/III not classified

Adverse event reports per year · MKJ

13,315in 2025

2007high 17,062 (2016) · low 3,958 (2007)2025

MAUDE reports naming product code MKJ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	7	69	12	3,958
2008	13	141	24	4,752
2009	8	165	37	6,782
2010	4	250	35	7,399
2011	11	36	7	8,170
2012	10	197	5 (1)	9,732
2013	7	191	4	14,955
2014	11	196	24 (15)	15,399
2015	6	156	1	16,129
2016	0	—	2 (1)	17,062
2017	4	—	6 (4)	16,684
2018	20	—	3	16,591
2019	25	—	6 (2)	16,861
2020	52	—	2	16,197
2021	41	—	4	16,300
2022	19	—	3	14,867
2023	24	—	11	13,766
2024	27	—	5	15,109
2025	48	—	1	13,315
2026	31	—	3	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K103186 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103186: Skintact Radiotransparent Multifunction Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103186

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026