510(k) · Cleared
ClearedDisposal Ecg Electrodes, Model Easyrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suzuken Co., Ltd. · DRX Electrode, Electrocardiograph
Cleared on Oct 13, 2009 after a 69-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).
- Decided
- Oct 13, 2009
- Review
- 69 days
- Class
- Class II
- Product code
- DRX
- Recalls
- None
- Predicates
- 1
The summary cites one number, which could not be confirmed as its predicate (see the table below).
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K070786 | FDA’s K070786 is X-Pod Adjustable Vertebral Body Replacement Our OCR of the scanned summary read K070786, FDA’s number for X-Pod Adjustable Vertebral Body Replacement (Theken Spine, LLC). Its FDA name has none of the distinctive words the summary uses for the device it names, “3M Red Dot 2560 Monitoring Electrode with Foam Tape and Stickey Gel”. Kept off the family tree. | 2007 |
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.
How does its category compare?
All DRX devicesDRX Electrode, Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 Easyrode is intended for use in ECG Monitoring. The Easyrode can be used in all ECG applications where standard ECG monitoring electrodes are used. This electrode can be used for short term and long term (2 Days) monitoring.
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/K092389 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092389: Disposal Ecg Electrodes, Model Easyrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092389
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026