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 Aug 21, 2009 as substantially equivalent to K030509 (Leonhard Lang GmbH, 2003) after a 23-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Aug 21, 2009
- Review
- 23 days
- Class
- Class II
- Product code
- DRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K960968 (1996). 6 ancestors in all, the oldest K944260 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK960968 Medi-Trace 200, Medi-Trace 200-30Graphic Controls Corp. · 1996
- 3 generations backK023503 Skintact Ecg ElectrodeLeonhard Lang GmbH · 2002
- 2 generations backK023920 SkintactLeonhard Lang GmbH · 2003
- 1 generation backK030509 Skintact Ecg Tab ElectrodeLeonhard Lang GmbH · 2003
- This deviceK092291 Skintact and Various Other TradenamesLeonhard Lang GmbH · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K960968 | Medi-Trace 200, Medi-Trace 200-30 | Graphic Controls Corp. | 1996 | — |
| −3 | K023503 | Skintact Ecg Electrode | Leonhard Lang GmbH | 2002 | — |
| −2 | K023920 | Skintact | Leonhard Lang GmbH | 2003 | — |
| −1 | K030509 | Skintact Ecg Tab Electrode | Leonhard Lang GmbH | 2003 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K030509 | Skintact Ecg Tab ElectrodeSummary page 1…iovascular: 74 DRX Reason for 510(k) Submission: change of material Substantial Equivalence: Skintact® EGG Tab Electrodes with KH06D Gel are substantially equivalent to K030509 "Leonhard Lang Skintact* EGG Ele6trodes with KHO6 Gel" and have the same indication for use. The only change between the original… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 13 years and passes through 2 companies; a new generation was cleared every 6.0 years on median.
- None of the 6 ancestors has a recall.
- 2 other devices also cite its predicate K030509.
How does its category compare?
All DRX devicesDRX Electrode, Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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/K092291 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092291: Skintact and Various Other Tradenames.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092291
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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