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 Nov 14, 2002 as substantially equivalent to K982521 (Leonhard Lang Co., 1999) and 1 other predicate after a 27-day review. Its family tree reaches back 1 generation to 1996. 8 later devices descend from it.
- Decided
- Nov 14, 2002
- Review
- 27 days
- Class
- Class II
- Product code
- DRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K960968 (1996). 2 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK960968 Medi-Trace 200, Medi-Trace 200-30Graphic Controls Corp. · 1996
- This deviceK023503 Skintact Ecg ElectrodeLeonhard Lang GmbH · 2002
- Descendant · cites it directly · 5 of its ownK023920 SkintactLeonhard Lang GmbH · 2003
- Descendant · 2 generations on · 4 of its ownK030509 Skintact Ecg Tab ElectrodeLeonhard Lang GmbH · 2003
- Descendant · cites it directly · 2 of its ownK073104 Skintact and Various Other TradenamesLeonhard Lang GmbH · 2007
- Descendant · 3 generations on · 1 of its ownK040784 Protab Ecg Tabb ElectrodeBio Protech, Inc. · 2004
- Descendant · 3 generations on · 0 of its ownK093327 Intco Tab ElectrodeShanghai Intco Electrode Manufacturing Co., Ltd. · 2010
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K023920SkintactLeonhard Lang GmbH · 2003 · cites it directly5descendants
- K030509Skintact Ecg Tab ElectrodeLeonhard Lang GmbH · 2003 · 2 generations on4descendants
- K073104Skintact and Various Other TradenamesLeonhard Lang GmbH · 2007 · cites it directly2descendants
- K040784Protab Ecg Tabb ElectrodeBio Protech, Inc. · 2004 · 3 generations on1descendant
- K093327Intco Tab ElectrodeShanghai Intco Electrode Manufacturing Co., Ltd. · 2010 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960968 | Medi-Trace 200, Medi-Trace 200-30 | Graphic Controls Corp. | 1996 | — |
| 0 (this device) | K023503 | Skintact Ecg Electrode | Leonhard Lang GmbH | 2002 | — |
| +1 | K023920 | Skintact | Leonhard Lang GmbH | 2003 | — |
| +2 | K030509 | Skintact Ecg Tab Electrode | Leonhard Lang GmbH | 2003 | — |
| +1 | K073104 | Skintact and Various Other Tradenames | Leonhard Lang GmbH | 2007 | — |
| +3 | K040784 | Protab Ecg Tabb Electrode | Bio Protech, Inc. | 2004 | — |
| +3 | K093327 | Intco Tab Electrode | Shanghai Intco Electrode Manufacturing Co., Ltd. | 2010 | — |
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 |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K982521 | Skintact Ecg Electrodes, S&W Ecg ElectrodesSummary page 1…act@ECG Electrodes with solid adhesive gel are substantially equivalent to the Skintact@ECG Electrodes with liquid gel (the manufacturer’s predicate device cleared under K98252 1). FDA previously cleared predicate solid adhesive gel electrodes in K960968. DESCRIPTIOIV of the DEVICE: Skintact’ E C G Electro… | 1999 |
| * | K960968 | Medi-Trace 200, Medi-Trace 200-30Summary page 1…e Skintact@ECG Electrodes with liquid gel (the manufacturer’s predicate device cleared under K98252 1). FDA previously cleared predicate solid adhesive gel electrodes in K960968. DESCRIPTIOIV of the DEVICE: Skintact’ E C G Electrodes (and as also to be oferedfor sale under various private label tradenames… | 1996 |
What descends from it? (8)
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?
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/K023503 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023503: 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/K023503
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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