510(k) · Cleared
ClearedSkintact Ecg Electrode
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 Feb 24, 2004 as substantially equivalent to K971444 (3M Medical Products Group, 1997) and 1 other predicate after a 21-day review. Its family tree reaches back 2 generations to 1993. 3 later devices descend from it.
- Decided
- Feb 24, 2004
- Review
- 21 days
- Class
- Class II
- Product code
- DRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K930312 (1993). 3 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK930312 3M Red Dot 2234 Radiolucent Monitoring Electrode3M Health Care, Ltd. · 1993
- 1 generation backK971444 3M Red Dot 2234 & 2266 Radiolucent Monitoring Electrodes3M Medical Products Group · 1997
- This deviceK040249 Skintact Ecg ElectrodeLeonhard Lang GmbH · 2004
- Descendant · cites it directly · 2 of its ownK073104 Skintact and Various Other TradenamesLeonhard Lang GmbH · 2007
- Descendant · 2 generations on · 0 of its ownK090496 Qwiklead Reusable Electrocardiograph Electrode PatchCardiac Lead Technologies, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK080106 Skintact Pre-Wired Ecg Electrodes with Conductive AdhesiveLeonhard Lang GmbH · 2008
Most influential descendants
Showing 3 of 3 · See all- K073104Skintact and Various Other TradenamesLeonhard Lang GmbH · 2007 · cites it directly2descendants
- K090496Qwiklead Reusable Electrocardiograph Electrode PatchCardiac Lead Technologies, Inc. · 2009 · 2 generations on0descendants
- K080106Skintact Pre-Wired Ecg Electrodes with Conductive AdhesiveLeonhard Lang GmbH · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930312 | 3M Red Dot 2234 Radiolucent Monitoring Electrode | 3M Health Care, Ltd. | 1993 | — |
| −1 | K971444 | 3M Red Dot 2234 & 2266 Radiolucent Monitoring Electrodes | 3M Medical Products Group | 1997 | — |
| 0 (this device) | K040249 | Skintact Ecg Electrode | Leonhard Lang GmbH | 2004 | — |
| +1 | K073104 | Skintact and Various Other Tradenames | Leonhard Lang GmbH | 2007 | — |
| +2 | K090496 | Qwiklead Reusable Electrocardiograph Electrode Patch | Cardiac Lead Technologies, Inc. | 2009 | — |
| +2 | 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 |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K971444 | 3M Red Dot 2234 & 2266 Radiolucent Monitoring ElectrodesSummary page 1…G Electrodes are substantially equivalent to the Skintact® ECG Electrodes (the manufacturer's predicate devices) and equivalent to predicate ECG electrodes cleared under K971444 and K991105. DESCRIPTION of the DEVICE: Skintact® ECG Electrodes (and as also to be offered for sale under various private label… | 1997 |
| * | K991105 | Ecg Electrode (Various)Summary page 1…are substantially equivalent to the Skintact® ECG Electrodes (the manufacturer's predicate devices) and equivalent to predicate ECG electrodes cleared under K971444 and K991105. DESCRIPTION of the DEVICE: Skintact® ECG Electrodes (and as also to be offered for sale under various private label tradenames)… | 1999 |
| * | — | Skintact® ECG Electrodes Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073104 | Skintact and Various Other Tradenames | 2007 | 2 |
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 11 years and passes through 3 companies; a new generation was cleared every 6.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K073104 (Leonhard Lang GmbH, 2007) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DRX devicesDRX Electrode, Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 radiolucent and MRI-compatible 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 radiolucent and MRI-compatible 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/K040249 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040249: Skintact Ecg Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040249
Report an extraction error
Are you the manufacturer?
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