510(k) · Cleared
ClearedElectrocardiograph (Ecg) Electrode, Non-Sterile
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio Protech, Inc. · DRX Electrode, Electrocardiograph
Cleared on Nov 7, 2002 as substantially equivalent to K982521 (Leonhard Lang Co., 1999) after a 309-day review. Its family tree reaches back 1 generation to 1999. 2 later devices descend from it.
- Decided
- Nov 7, 2002
- Review
- 309 days
- Class
- Class II
- Product code
- DRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K982521 (1999). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK982521 Skintact Ecg Electrodes, S&W Ecg ElectrodesLeonhard Lang Co. · 1999
- This deviceK020003 Electrocardiograph (Ecg) Electrode, Non-SterileBio Protech, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK040784 Protab Ecg Tabb ElectrodeBio Protech, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK090496 Qwiklead Reusable Electrocardiograph Electrode PatchCardiac Lead Technologies, Inc. · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K982521 | Skintact Ecg Electrodes, S&W Ecg Electrodes | Leonhard Lang Co. | 1999 | — |
| 0 (this device) | K020003 | Electrocardiograph (Ecg) Electrode, Non-Sterile | Bio Protech, Inc. | 2002 | — |
| +1 | K040784 | Protab Ecg Tabb Electrode | Bio Protech, Inc. | 2004 | — |
| +1 | K090496 | Qwiklead Reusable Electrocardiograph Electrode Patch | Cardiac Lead Technologies, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K982521 | Skintact Ecg Electrodes, S&W Ecg ElectrodesSummary page 2…to substantiate the 24 month shelf life claim. Conclusion: This device is substantially equivalent to the device approved as K982521. Bio ProTech, Inc. c/o Ms. Janna P. Tucker Official Correspondent Tucker & Associates 198 Avenue De La D'emerald… | 1999 |
What descends from it? (2)
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?
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?
ECG electrodes are used to record the following ECGs from a patient: Resting ECG, Exercise ECG and/or ambulatory (Holter) monitoring.
The intended patient population can be adult, pediatric and neonatal, while the environment of use can be hospital (or clinic), ambulance, or daily use environment (for Holter monitoring).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020003 · printed Nov 4, 2026
Cite this page
510(k) Report. “K020003: Electrocardiograph (Ecg) Electrode, Non-Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020003
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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