510(k) · Cleared
ClearedSkintact Ecg Electrodes, S&W Ecg Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Leonhard Lang Co. · DRX Electrode, Electrocardiograph
Cleared on Oct 26, 1999 after a 463-day review. The FDA summary names its predicate without a number. 13 later devices descend from it.
- Decided
- Oct 26, 1999
- Review
- 463 days
- Class
- Class II
- Product code
- DRX
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 6 citing it directly.
- This deviceK982521 Skintact Ecg Electrodes, S&W Ecg ElectrodesLeonhard Lang Co. · 1999
- Descendant · cites it directly · 8 of its ownK023503 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 · 2 generations on · 2 of its ownK073104 Skintact and Various Other TradenamesLeonhard Lang GmbH · 2007
- Descendant · cites it directly · 2 of its ownK020003 Electrocardiograph (Ecg) Electrode, Non-SterileBio Protech, Inc. · 2002
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K023503Skintact Ecg ElectrodeLeonhard Lang GmbH · 2002 · cites it directly8descendants
- 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 · 2 generations on2descendants
- K020003Electrocardiograph (Ecg) Electrode, Non-SterileBio Protech, Inc. · 2002 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982521 | Skintact Ecg Electrodes, S&W Ecg Electrodes | Leonhard Lang Co. | 1999 | — |
| +1 | 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 | — |
| +2 | K073104 | Skintact and Various Other Tradenames | Leonhard Lang GmbH | 2007 | — |
| +1 | K020003 | Electrocardiograph (Ecg) Electrode, Non-Sterile | Bio Protech, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 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? (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 |
|---|---|---|---|
| * | — | Skintact AG Electrodes Named without a submission number |
What descends from it? (13)
See all 136 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?
- Of its descendants, K023503 (Leonhard Lang GmbH, 2002) has gone furthest, with 8 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 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 recordings.
Skintact ECG electrodes are non-sterile and are to be used on intact (uninjured) skin.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982521 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982521: Skintact Ecg Electrodes, S&W Ecg Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982521
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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