510(k) · Cleared
ClearedDisposable Ecg Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kendall-Ltp · DRX Electrode, Electrocardiograph
Cleared on Jun 21, 1996 after a 322-day review. The FDA summary names its predicate without a number. 20 later devices descend from it.
- Decided
- Jun 21, 1996
- Review
- 322 days
- Class
- Class II
- Product code
- DRX
- Recalls
- None
- Predicates
- 0
20 later devices descend from it, 2 citing it directly.
- This deviceK953649 Disposable Ecg ElectrodeKendall-Ltp · 1996
- Descendant · cites it directly · 16 of its ownK013725 Meditron II Thesterthoscope SystemMeditron AS · 2002
- Descendant · 2 generations on · 13 of its ownK110704 SENSIDiacoustic Medical Devices (Pty), Ltd. · 2011
- Descendant · 3 generations on · 10 of its ownK121617 SensicardiacDiacoustic Medical (Pty) · 2012
- Descendant · 4 generations on · 9 of its ownK131044 Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd. · 2013
- Descendant · 5 generations on · 7 of its ownK181988 eMurmur IDCsd Labs GmbH · 2019
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K013725Meditron II Thesterthoscope SystemMeditron AS · 2002 · cites it directly16descendants
- K110704SENSIDiacoustic Medical Devices (Pty), Ltd. · 2011 · 2 generations on13descendants
- K121617SensicardiacDiacoustic Medical (Pty) · 2012 · 3 generations on10descendants
- K131044Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd. · 2013 · 4 generations on9descendants
- K181988eMurmur IDCsd Labs GmbH · 2019 · 5 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953649 | Disposable Ecg Electrode | Kendall-Ltp | 1996 | — |
| +1 | K013725 | Meditron II Thesterthoscope System | Meditron AS | 2002 | — |
| +2 | K110704 | SENSI | Diacoustic Medical Devices (Pty), Ltd. | 2011 | — |
| +3 | K121617 | Sensicardiac | Diacoustic Medical (Pty) | 2012 | — |
| +4 | K131044 | Sensicardiac Mobi Diagnostic Heart Murmur Application | Diacoustic Medical Devices (Pty), Ltd. | 2013 | — |
| +5 | K181988 | eMurmur ID | Csd Labs GmbH | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | — | NDM disposable ECG electrodes Named without a submission number | |
| * | — | Nikomed disposable ECG electrodes Named without a submission number |
What descends from it? (20)
See all 202 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, K013725 (Meditron AS, 2002) has gone furthest, with 16 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?
LMI Medical considers their ElectroBlue® ECG Electrodes to be safe and effective for use with electrocardiograph monitors which are used for recording the electric activity of the myocardium to detect abnormal transmission of small electrical impulses through the conductive tissue surrounding the heart, when used according to the intended procedures as related in the instructions accompanying the product.
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/K953649 · printed Nov 6, 2026
Cite this page
510(k) Report. “K953649: Disposable Ecg Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953649
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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