510(k) · Cleared
ClearedEcg Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Msb, Ltd. · DRX Electrode, Electrocardiograph
Cleared on Jul 7, 1995 after a 311-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Jul 7, 1995
- Review
- 311 days
- Class
- Class II
- Product code
- DRX
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK944260 Ecg ElectrodeMsb, Ltd. · 1995
- 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 · cites it directly · 0 of its ownK101685 IP-SETIntegral Process Sas · 2010 · Recalled
- 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
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K030509Skintact Ecg Tab ElectrodeLeonhard Lang GmbH · 2003 · cites it directly4descendants
- K040784Protab Ecg Tabb ElectrodeBio Protech, Inc. · 2004 · 2 generations on1descendant
- K101685IP-SETIntegral Process Sas · 2010 · cites it directly0descendants
- K093327Intco Tab ElectrodeShanghai Intco Electrode Manufacturing Co., Ltd. · 2010 · 2 generations on0descendants
- K090496Qwiklead Reusable Electrocardiograph Electrode PatchCardiac Lead Technologies, Inc. · 2009 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944260 | Ecg Electrode | Msb, Ltd. | 1995 | — |
| +1 | K030509 | Skintact Ecg Tab Electrode | Leonhard Lang GmbH | 2003 | — |
| +2 | K040784 | Protab Ecg Tabb Electrode | Bio Protech, Inc. | 2004 | — |
| +1 | K101685 | IP-SET | Integral Process Sas | 2010 | 6 |
| +2 | K093327 | Intco Tab Electrode | Shanghai Intco Electrode Manufacturing Co., Ltd. | 2010 | — |
| +3 | K090496 | Qwiklead Reusable Electrocardiograph Electrode Patch | Cardiac Lead Technologies, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
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, K030509 (Leonhard Lang GmbH, 2003) has gone furthest, with 4 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/K944260 · printed Nov 5, 2026
Cite this page
510(k) Report. “K944260: Ecg Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K944260
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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