510(k) · Cleared
Recalled · 2003Ecg Electrode (Various)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmedcorp · DRX Electrode, Electrocardiograph
Cleared on Nov 26, 1999 after a 239-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it. It has been recalled once.
- Decided
- Nov 26, 1999
- Review
- 239 days
- Class
- Class II
- Product code
- DRX
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK991105 Ecg Electrode (Various)Conmedcorp · 1999
- Descendant · cites it directly · 3 of its ownK040249 Skintact Ecg ElectrodeLeonhard Lang GmbH · 2004
- Descendant · 2 generations on · 2 of its ownK073104 Skintact and Various Other TradenamesLeonhard Lang GmbH · 2007
- Descendant · 3 generations on · 0 of its ownK090496 Qwiklead Reusable Electrocardiograph Electrode PatchCardiac Lead Technologies, Inc. · 2009
- Descendant · 3 generations on · 0 of its ownK080106 Skintact Pre-Wired Ecg Electrodes with Conductive AdhesiveLeonhard Lang GmbH · 2008
Most influential descendants
Showing 4 of 4 · See all- K040249Skintact Ecg ElectrodeLeonhard Lang GmbH · 2004 · cites it directly3descendants
- K073104Skintact and Various Other TradenamesLeonhard Lang GmbH · 2007 · 2 generations on2descendants
- K090496Qwiklead Reusable Electrocardiograph Electrode PatchCardiac Lead Technologies, Inc. · 2009 · 3 generations on0descendants
- K080106Skintact Pre-Wired Ecg Electrodes with Conductive AdhesiveLeonhard Lang GmbH · 2008 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991105 | Ecg Electrode (Various) | Conmedcorp | 1999 | — |
| +1 | K040249 | Skintact Ecg Electrode | Leonhard Lang GmbH | 2004 | — |
| +2 | K073104 | Skintact and Various Other Tradenames | Leonhard Lang GmbH | 2007 | — |
| +3 | K090496 | Qwiklead Reusable Electrocardiograph Electrode Patch | Cardiac Lead Technologies, Inc. | 2009 | — |
| +3 | K080106 | Skintact Pre-Wired Ecg Electrodes with Conductive Adhesive | Leonhard Lang GmbH | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040249 | Skintact Ecg Electrode | 2004 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 30, 2003 | Not classified | Z-1184-03 | Other | Separation of the sensing element from the body of the electrode. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K040249 (Leonhard Lang GmbH, 2004) has gone furthest, with 3 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?
An electrical conductor applied to a patient’s skin to transmit electrical signals at the body surface to a monitor for diagnosis of ailments by health professionals. The electrodes, without a lead wire or cable connected, are MR safe and not MRI compatible as a stand alone device.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991105 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991105: Ecg Electrode (Various).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991105
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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