510(k) · Cleared
ClearedSkintact
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 Jan 16, 2003 as substantially equivalent to K023503 (Leonhard Lang GmbH, 2002) and 1 other predicate after a 52-day review. Its family tree reaches back 2 generations to 1996. 5 later devices descend from it.
- Decided
- Jan 16, 2003
- Review
- 52 days
- Class
- Class II
- Product code
- DRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K960968 (1996). 3 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK960968 Medi-Trace 200, Medi-Trace 200-30Graphic Controls Corp. · 1996
- 1 generation backK023503 Skintact Ecg ElectrodeLeonhard Lang GmbH · 2002
- This deviceK023920 SkintactLeonhard Lang GmbH · 2003
- Descendant · cites it directly · 4 of its ownK030509 Skintact Ecg Tab ElectrodeLeonhard Lang GmbH · 2003
- Descendant · 2 generations on · 1 of its ownK040784 Protab Ecg Tabb ElectrodeBio Protech, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK093327 Intco Tab ElectrodeShanghai Intco Electrode Manufacturing Co., Ltd. · 2010
- Descendant · 3 generations on · 0 of its ownK090496 Qwiklead Reusable Electrocardiograph Electrode PatchCardiac Lead Technologies, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK092291 Skintact and Various Other TradenamesLeonhard Lang GmbH · 2009
Most influential descendants
Showing 5 of 5 · See all- K030509Skintact Ecg Tab ElectrodeLeonhard Lang GmbH · 2003 · cites it directly4descendants
- K040784Protab Ecg Tabb ElectrodeBio Protech, Inc. · 2004 · 2 generations on1descendant
- K093327Intco Tab ElectrodeShanghai Intco Electrode Manufacturing Co., Ltd. · 2010 · 2 generations on0descendants
- K090496Qwiklead Reusable Electrocardiograph Electrode PatchCardiac Lead Technologies, Inc. · 2009 · 3 generations on0descendants
- K092291Skintact and Various Other TradenamesLeonhard Lang GmbH · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K960968 | Medi-Trace 200, Medi-Trace 200-30 | Graphic Controls Corp. | 1996 | — |
| −1 | K023503 | Skintact Ecg Electrode | Leonhard Lang GmbH | 2002 | — |
| 0 (this device) | K023920 | Skintact | Leonhard Lang GmbH | 2003 | — |
| +1 | K030509 | Skintact Ecg Tab Electrode | Leonhard Lang GmbH | 2003 | — |
| +2 | K040784 | Protab Ecg Tabb Electrode | Bio Protech, Inc. | 2004 | — |
| +2 | K093327 | Intco Tab Electrode | Shanghai Intco Electrode Manufacturing Co., Ltd. | 2010 | — |
| +3 | K090496 | Qwiklead Reusable Electrocardiograph Electrode Patch | Cardiac Lead Technologies, Inc. | 2009 | — |
| +2 | K092291 | Skintact and Various Other Tradenames | Leonhard Lang GmbH | 2009 | — |
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 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K023503 | Skintact Ecg ElectrodeSummary page 1…cTec Corporation. Leonhard Lang has predicate ECG electrodes (same procode) of different materials and construction design cleared in previous 510(k) submissions such as K 023503 and K 982521. DESCRIPTION of the DEVICE: Skintact@ECG Tab Electrodes (and as also to be oferedfor sale under various private lab… | 2002 |
| * | K982521 | Skintact Ecg Electrodes, S&W Ecg ElectrodesSummary page 1…ion. Leonhard Lang has predicate ECG electrodes (same procode) of different materials and construction design cleared in previous 510(k) submissions such as K 023503 and K 982521. DESCRIPTION of the DEVICE: Skintact@ECG Tab Electrodes (and as also to be oferedfor sale under various private label tradenames… | 1999 |
| * | — | Tracet Ag 4000 electrodes by LecTec Corporation Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030509 | Skintact Ecg Tab Electrode | 2003 | 4 |
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 6.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K030509 (Leonhard Lang GmbH, 2003) has gone furthest, with 4 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.
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/K023920 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023920: Skintact.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023920
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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