510(k) · Cleared
ClearedBodytrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Marquette Electronics, Inc. · DRX Electrode, Electrocardiograph
Cleared on Aug 8, 1996 as substantially equivalent to K833695 (Marquette Electronics, Inc., 1984) after a 126-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Aug 8, 1996
- Review
- 126 days
- Class
- Class II
- Product code
- DRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K833695 (1984). No later device cites it as a predicate yet.
- Root · 1 generation backK833695 Adult Monitoring Elector@@Rode 9431-300Marquette Electronics, Inc. · 1984
- This deviceK961288 BodytrodeMarquette Electronics, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K833695 | Adult Monitoring Elector@@Rode 9431-300 | Marquette Electronics, Inc. | 1984 | — |
| 0 (this device) | K961288 | Bodytrode | Marquette Electronics, Inc. | 1996 | — |
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 |
|---|---|---|---|
| * | K833695 | Adult Monitoring Elector@@Rode 9431-300Summary page 1…ished under section 514 3. Substantial Equivalence: BodyTrode is substantially equivalent to Marquette ECG electrodes which are currently legally marketed under 510(k) 833695. 4. Device Description: The Marquette BodyTrode ECG Electrodes are adhesive hydrogelled, single use ECG electrodes intended for… | 1984 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
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?
The BodyTrode is a short term, single use (disposable), adult and pediatric ECG electrode which is applied to the intact skin surface to acquire electrocardiographic activity of the heart which can be displayed and analyzed when used in combination with leadwires, cables, and a monitor. They are intended to be used in both hospital and prehospital settings under the direction of a licensed health care practitioner.
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/K961288 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961288: Bodytrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961288
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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