510(k) · Cleared
ClearedSkintact Ecg Tab 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 Mar 4, 2003 as substantially equivalent to K023920 (Leonhard Lang GmbH, 2003) and 1 other predicate after a 13-day review. Its family tree reaches back 3 generations to 1996. 4 later devices descend from it.
- Decided
- Mar 4, 2003
- Review
- 13 days
- Class
- Class II
- Product code
- DRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K960968 (1996). 5 ancestors in all, the oldest K944260 (1995). 4 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK960968 Medi-Trace 200, Medi-Trace 200-30Graphic Controls Corp. · 1996
- 2 generations backK023503 Skintact Ecg ElectrodeLeonhard Lang GmbH · 2002
- 1 generation backK023920 SkintactLeonhard Lang GmbH · 2003
- This deviceK030509 Skintact Ecg Tab ElectrodeLeonhard Lang GmbH · 2003
- Descendant · cites it directly · 1 of its ownK040784 Protab Ecg Tabb ElectrodeBio Protech, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK093327 Intco Tab ElectrodeShanghai Intco Electrode Manufacturing Co., Ltd. · 2010
- Descendant · 2 generations on · 0 of its ownK090496 Qwiklead Reusable Electrocardiograph Electrode PatchCardiac Lead Technologies, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK092291 Skintact and Various Other TradenamesLeonhard Lang GmbH · 2009
Most influential descendants
Showing 4 of 4 · See all- K040784Protab Ecg Tabb ElectrodeBio Protech, Inc. · 2004 · cites it directly1descendant
- K093327Intco Tab ElectrodeShanghai Intco Electrode Manufacturing Co., Ltd. · 2010 · cites it directly0descendants
- K090496Qwiklead Reusable Electrocardiograph Electrode PatchCardiac Lead Technologies, Inc. · 2009 · 2 generations on0descendants
- K092291Skintact and Various Other TradenamesLeonhard Lang GmbH · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960968 | Medi-Trace 200, Medi-Trace 200-30 | Graphic Controls Corp. | 1996 | — |
| −2 | K023503 | Skintact Ecg Electrode | Leonhard Lang GmbH | 2002 | — |
| −1 | K023920 | Skintact | Leonhard Lang GmbH | 2003 | — |
| 0 (this device) | K030509 | Skintact Ecg Tab Electrode | Leonhard Lang GmbH | 2003 | — |
| +1 | K040784 | Protab Ecg Tabb Electrode | Bio Protech, Inc. | 2004 | — |
| +1 | K093327 | Intco Tab Electrode | Shanghai Intco Electrode Manufacturing Co., Ltd. | 2010 | — |
| +2 | K090496 | Qwiklead Reusable Electrocardiograph Electrode Patch | Cardiac Lead Technologies, Inc. | 2009 | — |
| +1 | K092291 | Skintact and Various Other Tradenames | Leonhard Lang GmbH | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 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? (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 | Decided |
|---|---|---|---|
| * | K023920 | SkintactSummary page 1…NT TO: Skintact@ECG Tab Electrodes with KH 06 gel are substantially equivalent to the Skintact@ECG Tab Electrodes with LecTec LT 4900 gel (the manufacterer's predicate - K023920). The additional carbon ink layer added for performance, is substantially equivalent to the MSB electrode (now distributed as Nik… | 2003 |
| * | K944260 | Ecg ElectrodeSummary page 1…- K023920). The additional carbon ink layer added for performance, is substantially equivalent to the MSB electrode (now distributed as Nikotab) originally cleared under K944260. DESCRIPTION of the DEVICE: Skintact@ECG Tab Electrodes (and also to be sold under various private fabel tmcfenarnrs) will be of… | 1995 |
What descends from it? (4)
3 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 7 years and passes through 2 companies; a new generation was cleared every 2 months on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K040784 (Bio Protech, Inc., 2004) has gone furthest, with 1 descendant 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 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 non-sterile and are to be used on intact (uninjured) skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030509 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030509: Skintact Ecg Tab Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030509
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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