510(k) · Cleared
ClearedSkintact and Various Other Tradenames
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Leonhard Lang GmbH · DRX Electrode, Electrocardiograph
Cleared on Nov 16, 2007 as substantially equivalent to K023503 (Leonhard Lang GmbH, 2002) and 3 other predicates after a 14-day review. Its family tree reaches back 3 generations to 1993. 2 later devices descend from it.
- Decided
- Nov 16, 2007
- Review
- 14 days
- Class
- Class II
- Product code
- DRX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K930312 (1993). 9 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK930312 3M Red Dot 2234 Radiolucent Monitoring Electrode3M Health Care, Ltd. · 1993
- 2 generations backK971444 3M Red Dot 2234 & 2266 Radiolucent Monitoring Electrodes3M Medical Products Group · 1997
- 1 generation backK040249 Skintact Ecg ElectrodeLeonhard Lang GmbH · 2004
- This deviceK073104 Skintact and Various Other TradenamesLeonhard Lang GmbH · 2007
- Descendant · cites it directly · 0 of its ownK090496 Qwiklead Reusable Electrocardiograph Electrode PatchCardiac Lead Technologies, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK080106 Skintact Pre-Wired Ecg Electrodes with Conductive AdhesiveLeonhard Lang GmbH · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930312 | 3M Red Dot 2234 Radiolucent Monitoring Electrode | 3M Health Care, Ltd. | 1993 | — |
| −2 | K971444 | 3M Red Dot 2234 & 2266 Radiolucent Monitoring Electrodes | 3M Medical Products Group | 1997 | — |
| −1 | K040249 | Skintact Ecg Electrode | Leonhard Lang GmbH | 2004 | — |
| 0 (this device) | K073104 | Skintact and Various Other Tradenames | Leonhard Lang GmbH | 2007 | — |
| +1 | K090496 | Qwiklead Reusable Electrocardiograph Electrode Patch | Cardiac Lead Technologies, Inc. | 2009 | — |
| +1 | K080106 | Skintact Pre-Wired Ecg Electrodes with Conductive Adhesive | Leonhard Lang GmbH | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K023503 | Skintact Ecg ElectrodeSummary page 1…he same as predicate devices and passed ISO 10993 for intact skin. The performiance data of Skintact"' EGG Electrodes with Conductive Adhesive and the predicate devices (K023503, K040249) met specifications as established in ANSI/AAMI ECI12:2000. The shelf life of Skintactw EGG Electrodes with Conductive A… | 2002 |
| * | K040249 | Skintact Ecg ElectrodeSummary page 1…s predicate devices and passed ISO 10993 for intact skin. The performiance data of Skintact"' EGG Electrodes with Conductive Adhesive and the predicate devices (K023503, K040249) met specifications as established in ANSI/AAMI ECI12:2000. The shelf life of Skintactw EGG Electrodes with Conductive Adhesive w… | 2004 |
| * | K000690 | 3M Red Dot Radiolucent Monitoring Electrode with Conductive AdhesiveSummary page 1…ufacturer. K(023503 Leouhard Lang Skintact"' EGG Electrodes with solid adhesive gel K(040249 Leonhard Lang Skintact' radiolucent and MRI-compatible EGG Electrodes K(000690 3M Red [)ot Radiolucent Monitoring Electrode with Conductive Adhesive K(000206 Pals Neonatal Pediatric EGG Electrodes, Models PN… | 2000 |
| * | K000206 | Pals Neonatal Pediatric Ecg Electrode, Models PN100, PN200Summary page 1…e gel K(040249 Leonhard Lang Skintact' radiolucent and MRI-compatible EGG Electrodes K(000690 3M Red [)ot Radiolucent Monitoring Electrode with Conductive Adhesive K(000206 Pals Neonatal Pediatric EGG Electrodes, Models PNIOO PN200 Description of device: All SkintactS EGG Electrodes are self-adhesive… | 2000 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K090496 (Cardiac Lead Technologies, Inc., 2009) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K023503.
How does its category compare?
All DRX devicesDRX Electrode, Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · DRX
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · DRX
78in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRX
6in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRX
250in 2025
MAUDE reports naming product code DRX, 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 | 3 | 147 | 0 | 47 |
| 2008 | 3 | 17 | 0 | 15 |
| 2009 | 7 | 89 | 0 | 36 |
| 2010 | 5 | 78 | 4 | 48 |
| 2011 | 0 | — | 0 | 80 |
| 2012 | 0 | — | 0 | 41 |
| 2013 | 1 | — | 0 | 70 |
| 2014 | 1 | — | 0 | 27 |
| 2015 | 0 | — | 1 | 58 |
| 2016 | 0 | — | 0 | 37 |
| 2017 | 1 | — | 0 | 55 |
| 2018 | 0 | — | 0 | 43 |
| 2019 | 0 | — | 0 | 50 |
| 2020 | 0 | — | 5 | 53 |
| 2021 | 0 | — | 1 | 55 |
| 2022 | 0 | — | 6 | 61 |
| 2023 | 0 | — | 0 | 113 |
| 2024 | 0 | — | 0 | 61 |
| 2025 | 0 | — | 0 | 250 |
| 2026 | 0 | — | 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.
https://510kreport.com/device/K073104 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073104: Skintact and Various Other Tradenames.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073104
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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