510(k) · Cleared
Cleared3M Red Dot Radiolucent Monitoring Electrode with Conductive Adhesive
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Minnesota Mining and Mfg. Co. · DRX Electrode, Electrocardiograph
Cleared on May 17, 2000 after a 78-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- May 17, 2000
- Review
- 78 days
- Class
- Class II
- Product code
- DRX
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK000690 3M Red Dot Radiolucent Monitoring Electrode with Conductive AdhesiveMinnesota Mining and Mfg. Co. · 2000
- Descendant · cites it directly · 2 of its ownK073104 Skintact and Various Other TradenamesLeonhard Lang GmbH · 2007
- Descendant · cites it directly · 0 of its ownK140096 Hmicro Wired C-Patch Electrode, Trade Name Subject to ChangeHmicro, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK090496 Qwiklead Reusable Electrocardiograph Electrode PatchCardiac Lead Technologies, Inc. · 2009
- Descendant · 2 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- K073104Skintact and Various Other TradenamesLeonhard Lang GmbH · 2007 · cites it directly2descendants
- K140096Hmicro Wired C-Patch Electrode, Trade Name Subject to ChangeHmicro, Inc. · 2014 · cites it directly0descendants
- K090496Qwiklead Reusable Electrocardiograph Electrode PatchCardiac Lead Technologies, Inc. · 2009 · 2 generations on0descendants
- K080106Skintact Pre-Wired Ecg Electrodes with Conductive AdhesiveLeonhard Lang GmbH · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000690 | 3M Red Dot Radiolucent Monitoring Electrode with Conductive Adhesive | Minnesota Mining and Mfg. Co. | 2000 | — |
| +1 | K073104 | Skintact and Various Other Tradenames | Leonhard Lang GmbH | 2007 | — |
| +1 | K140096 | Hmicro Wired C-Patch Electrode, Trade Name Subject to Change | Hmicro, Inc. | 2014 | — |
| +2 | K090496 | Qwiklead Reusable Electrocardiograph Electrode Patch | Cardiac Lead Technologies, Inc. | 2009 | — |
| +2 | 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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
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?
- Of its descendants, K073104 (Leonhard Lang GmbH, 2007) has gone furthest, with 2 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 | — |
https://510kreport.com/device/K000690 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000690: 3M Red Dot Radiolucent Monitoring Electrode with Conductive Adhesive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000690
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026