510(k) Report

510(k) · Cleared

Cleared

Skintact Pre-Wired Ecg Electrodes with Conductive Adhesive

K080106510(k) SpecialCleared Feb 1, 200817-day reviewClass II21 CFR 870.2360

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

Leonhard Lang GmbH · DRX Electrode, Electrocardiograph

Cleared on Feb 1, 2008 as substantially equivalent to K073104 (Leonhard Lang GmbH, 2007) and 3 other predicates after a 17-day review. Its family tree reaches back 4 generations to 1993.

Decided
Feb 1, 2008
Review
17 days
Class
Class II
Product code
DRX
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K930312 (1993). 12 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 1 other ancestor2005: 1 other ancestor2000: 2 other ancestors2002: 1 other ancestor1999: 2 other ancestors1996: 1 other ancestorK930312 · 3M Red Dot 2234 Radiolucent Monitoring Electrode · 3M Health Care, Ltd. · 1993K971444 · 3M Red Dot 2234 & 2266 Radiolucent Monitoring Electrodes · 3M Medical Products Group · 1997K040249 · Skintact Ecg Electrode · Leonhard Lang GmbH · 2004K073104 · Skintact and Various Other Tradenames · Leonhard Lang GmbH · 200719901995200020052010
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 2 other ancestors3 generations back: 3 other ancestors K073104 · Skintact and Various Other Tradenames · Leonhard Lang GmbH · 2007K040249 · Skintact Ecg Electrode · Leonhard Lang GmbH · 2004K971444 · 3M Red Dot 2234 & 2266 Radiolucent Monitoring Electrodes · 3M Medical Products Group · 1997K930312 · 3M Red Dot 2234 Radiolucent Monitoring Electrode · 3M Health Care, Ltd. · 19930
  1. Root · 4 generations backK930312 3M Red Dot 2234 Radiolucent Monitoring Electrode3M Health Care, Ltd. · 1993
  2. 3 generations backK971444 3M Red Dot 2234 & 2266 Radiolucent Monitoring Electrodes3M Medical Products Group · 1997
  3. 2 generations backK040249 Skintact Ecg ElectrodeLeonhard Lang GmbH · 2004
  4. 1 generation backK073104 Skintact and Various Other TradenamesLeonhard Lang GmbH · 2007
  5. This deviceK080106 Skintact Pre-Wired Ecg Electrodes with Conductive AdhesiveLeonhard Lang GmbH · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K9303123M Red Dot 2234 Radiolucent Monitoring Electrode3M Health Care, Ltd.1993—
−3K9714443M Red Dot 2234 & 2266 Radiolucent Monitoring Electrodes3M Medical Products Group1997—
−2K040249Skintact Ecg ElectrodeLeonhard Lang GmbH2004—
−1K073104Skintact and Various Other TradenamesLeonhard Lang GmbH2007—
0 (this device)K080106Skintact Pre-Wired Ecg Electrodes with Conductive AdhesiveLeonhard Lang GmbH2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199920
200020
200210
200510
200610
FIG. 1 — Lineage of K080106, 1993–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

Planning a device in DRX? 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? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K073104Skintact and Various Other Tradenames
Summary page 1
…0(k) Submission: addition of pre-attached lead wire Substantial Equivalence: Skintact" Pre-wired ECG Electrodes with Conductive Adhesive are substantially equivalent to K073104 Leonhai'd Lang Skintactt ECG Electrodes with Conductive Adhesive and have the same indications for use. The only change between t…
Leonhard Lang GmbH2007—
*K000206Pals Neonatal Pediatric Ecg Electrode, Models PN100, PN200
Summary page 1
…eonhard Lang Skintact® Pre-wired ECG Electrodes with Conductive Adhesive met specifications as established in ANSI/AAMI EC12:2000, as did the predicate devices (K073104, K000206, K053011, K053550). The shelf life of Skintact® Pre-wired ECG Electrodes with Conductive Adhesive was tested in accelerated aging…
Axelgaard Mfg. Co., Ltd.2000—
*K053011Pro-Neo Neonatal Ecg Electrode, Models SG15 and SR20
Summary page 1
…ve been previously cleared in predicate devices using similar materials: K(000206 Pals Neonatal Pediatric ECG Electrode K053011 Pro-Neo Neonatal ECG Electrode K(053550 Ambu Blue sensor Neo and Neo X Description of device: All Skint…
Bio Protech, Inc.2005—
*K053550Ambu Blue Sensor Neo and Neo X
Summary page 1
…act® Pre-wired ECG Electrodes with Conductive Adhesive met specifications as established in ANSI/AAMI EC12:2000, as did the predicate devices (K073104, K000206, K053011, K053550). The shelf life of Skintact® Pre-wired ECG Electrodes with Conductive Adhesive was tested in accelerated aging in the same marne…
Ambu A/S2006—

Also cleared against K073104: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
  • 1 of the 12 ancestors has a recall of any class.
  • 1 other device also cites its predicate K073104.

How does its category compare?

All DRX devices

DRX Electrode, Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · DRX

1in 2017

2007: 32008: 32009: 72010: 52013: 12014: 12017: 1
2007high 7 (2009) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRX

78in 2010

2007: 147 days median2008: 17 days median2009: 89 days median2010: 78 days median
2007high 147 (2007) · low 17 (2008)2026

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

Recalls per year · DRX

6in 2022

2010: 42015: 12020: 52021: 12022: 6
2007high 6 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DRX

250in 2025

2007: 472008: 152009: 362010: 482011: 802012: 412013: 702014: 272015: 582016: 372017: 552018: 432019: 502020: 532021: 552022: 612023: 1132024: 612025: 250
2007high 250 (2025) · low 15 (2008)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20073147047
2008317015
2009789036
2010578448
20110—080
20120—041
20131—070
20141—027
20150—158
20160—037
20171—055
20180—043
20190—050
20200—553
20210—155
20220—661
20230—0113
20240—061
20250—0250
20260—0—

What is it indicated for?

Skintact ECG Electrodes are designed for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician. Such procedures include in particular patient ECG surveillance and ECG diagnosis recording.

Skintact ECG Electrodes are single use, non-sterile and disposable and are to be used on intact (uninjured) skin.

Indications for use as stated in the FDA summary.

Also cleared against K073104

1 other device cites the same predicate.

  • K090496Qwiklead Reusable Electrocardiograph Electrode PatchCardiac Lead Technologies, Inc. · 2009

More from Leonhard Lang GmbH

17 FDA decisions under this applicant name. See the company

  • K142803Skintact, various other tradenamesLeonhard Lang GmbH · 20142 Class I recalls
  • K140500SkintactLeonhard Lang GmbH · 2014
  • K140340SkintactLeonhard Lang GmbH · 2014
  • K103186Skintact Radiotransparent Multifunction ElectrodesLeonhard Lang GmbH · 2011
  • K092291Skintact and Various Other TradenamesLeonhard Lang GmbH · 2009

Recent decisions in DRX

The DRX category page

  • K171244PhysiotraceNimbleheart, Inc. · 2017
  • K140096Hmicro Wired C-Patch Electrode, Trade Name Subject to ChangeHmicro, Inc. · 2014
  • K123658Biomodule 3-M1Zephyr Technology Corporation · 2013
  • K101576Centerridge Diagnostic Ecg Electrode, Centerridge Monitoring Ecg ElectrodesTeam Innovations, Inc. · 2010
  • K101685IP-SETIntegral Process Sas · 20106 recalls

https://510kreport.com/device/K080106 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080106: Skintact Pre-Wired Ecg Electrodes with Conductive Adhesive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080106

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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