510(k) · Cleared
ClearedAmbu Blue Sensor, MRX, Ecg Electrode Product #:MRX-00-S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ambu, Inc. · DRX Electrode, Electrocardiograph
Cleared on Jun 28, 2004 as substantially equivalent to K983689 (Medicotest A/S, 1999) after a 68-day review. Its family tree reaches back 1 generation to 1999. 4 later devices descend from it.
- Decided
- Jun 28, 2004
- Review
- 68 days
- Class
- Class II
- Product code
- DRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K983689 (1999). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK983689 Blue Sensor Supatab,Disposable Ecg ElectrodesMedicotest A/S · 1999
- This deviceK041026 Ambu Blue Sensor, MRX, Ecg Electrode Product #:MRX-00-SAmbu, Inc. · 2004
- Descendant · cites it directly · 3 of its ownK140862 Monica Novii Wireless Patch SystemMonica Healthcare, Ltd. · 2014 · Recalled
- Descendant · 2 generations on · 1 of its ownK231964 Novii+ Wireless Patch SystemDatex Ohmeda · 2023
- Descendant · 3 generations on · 0 of its ownK254036 Novii+ Wireless Patch SystemDatex Ohmeda, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK233440 Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal &…Philips Medizin Systeme Boeblingen GmbH · 2024
Most influential descendants
Showing 4 of 4 · See all- K140862Monica Novii Wireless Patch SystemMonica Healthcare, Ltd. · 2014 · cites it directly3descendants
- K231964Novii+ Wireless Patch SystemDatex Ohmeda · 2023 · 2 generations on1descendant
- K254036Novii+ Wireless Patch SystemDatex Ohmeda, Inc. · 2026 · 3 generations on0descendants
- K233440Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch…Philips Medizin Systeme Boeblingen GmbH · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983689 | Blue Sensor Supatab,Disposable Ecg Electrodes | Medicotest A/S | 1999 | — |
| 0 (this device) | K041026 | Ambu Blue Sensor, MRX, Ecg Electrode Product #:MRX-00-S | Ambu, Inc. | 2004 | — |
| +1 | K140862 | Monica Novii Wireless Patch System | Monica Healthcare, Ltd. | 2014 | 2 |
| +2 | K231964 | Novii+ Wireless Patch System | Datex Ohmeda | 2023 | — |
| +3 | K254036 | Novii+ Wireless Patch System | Datex Ohmeda, Inc. | 2026 | — |
| +2 | K233440 | Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal… | Philips Medizin Systeme Boeblingen GmbH | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K983689 | Blue Sensor Supatab,Disposable Ecg ElectrodesSummary page 2…tient use only. Predicate Device: The predicate device used for the purpose of substantial equivalence under this submission was the Blue Sensor SUPAtab ECG Electrode (K983689). The MRX electrode under this submission is almost identical with the SUPAtab electrode. The most important change is that the m… | 1999 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140862 | Monica Novii Wireless Patch System | 2014 | 3 |
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.
- Of its descendants, K140862 (Monica Healthcare, Ltd., 2014) has gone furthest, with 3 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?
The MRX disposable ECG electrode is applied to the surface of the body to transmit the electrical signal at the body surface to a processor in order to produce an electrocardiogram or vectorcardiogram.
The electrode is designed for use in MR environment and made for X-ray purposes, therefbre the electrode is MR safe and X-ray translucent.
The electrode is made for single patient use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041026 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041026: Ambu Blue Sensor, MRX, Ecg Electrode Product #:MRX-00-S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041026
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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