510(k) · Cleared
ClearedBlue Sensor Supatab,Disposable Ecg Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicotest A/S · DRX Electrode, Electrocardiograph
Cleared on Jan 15, 1999 after an 87-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Jan 15, 1999
- Review
- 87 days
- Class
- Class II
- Product code
- DRX
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK983689 Blue Sensor Supatab,Disposable Ecg ElectrodesMedicotest A/S · 1999
- Descendant · cites it directly · 4 of its ownK041026 Ambu Blue Sensor, MRX, Ecg Electrode Product #:MRX-00-SAmbu, Inc. · 2004
- Descendant · 2 generations on · 3 of its ownK140862 Monica Novii Wireless Patch SystemMonica Healthcare, Ltd. · 2014 · Recalled
- Descendant · 3 generations on · 1 of its ownK231964 Novii+ Wireless Patch SystemDatex Ohmeda · 2023
- Descendant · 4 generations on · 0 of its ownK254036 Novii+ Wireless Patch SystemDatex Ohmeda, Inc. · 2026
- Descendant · 3 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 5 of 5 · See all- K041026Ambu Blue Sensor, MRX, Ecg Electrode Product #:MRX-00-SAmbu, Inc. · 2004 · cites it directly4descendants
- K140862Monica Novii Wireless Patch SystemMonica Healthcare, Ltd. · 2014 · 2 generations on3descendants
- K231964Novii+ Wireless Patch SystemDatex Ohmeda · 2023 · 3 generations on1descendant
- K254036Novii+ Wireless Patch SystemDatex Ohmeda, Inc. · 2026 · 4 generations on0descendants
- K233440Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch…Philips Medizin Systeme Boeblingen GmbH · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983689 | Blue Sensor Supatab,Disposable Ecg Electrodes | Medicotest A/S | 1999 | — |
| +1 | K041026 | Ambu Blue Sensor, MRX, Ecg Electrode Product #:MRX-00-S | Ambu, Inc. | 2004 | — |
| +2 | K140862 | Monica Novii Wireless Patch System | Monica Healthcare, Ltd. | 2014 | 2 |
| +3 | K231964 | Novii+ Wireless Patch System | Datex Ohmeda | 2023 | — |
| +4 | K254036 | Novii+ Wireless Patch System | Datex Ohmeda, Inc. | 2026 | — |
| +3 | 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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2014 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041026 | Ambu Blue Sensor, MRX, Ecg Electrode Product #:MRX-00-S | 2004 | 4 |
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, K041026 (Ambu, Inc., 2004) has gone furthest, with 4 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 ECG electrode is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produce an electrocardiogram or vectorcardiogram. For single patient use only. The electrode is designed for resting ECG.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983689 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983689: Blue Sensor Supatab,Disposable Ecg Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983689
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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