510(k) · Cleared
ClearedDisposable Ecg Monitoring Electrodes, Models 4060, 4610
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maersk Medical A/S · DRX Electrode, Electrocardiograph
Cleared on Dec 6, 1999 as substantially equivalent to K950479 (Nikomed U.S.A., Inc., 1995) after a 327-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Dec 6, 1999
- Review
- 327 days
- Class
- Class II
- Product code
- DRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K950479 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK950479 Disposable Ecg Monitoring Electrode #4600 60MM, #4610 45MMNikomed U.S.A., Inc. · 1995
- This deviceK990112 Disposable Ecg Monitoring Electrodes, Models 4060, 4610Maersk Medical A/S · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950479 | Disposable Ecg Monitoring Electrode #4600 60MM, #4610 45MM | Nikomed U.S.A., Inc. | 1995 | — |
| 0 (this device) | K990112 | Disposable Ecg Monitoring Electrodes, Models 4060, 4610 | Maersk Medical A/S | 1999 | — |
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 |
|---|---|---|---|
| * | K950479 | Disposable Ecg Monitoring Electrode #4600 60MM, #4610 45MMSummary page 2…and design, and have the same intended use as the legally marketed disposable ECG monitoring electrodes Models 4600 and 4610 previously distributed by Nikomed USA, Inc. (K950479). Accordingly, Maersk Medical A/S concluded that the Niko ECG Monitoring Electrodes Models 4060 and 4610 are safe and effective f… | 1995 |
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?
ECG monitoring electrodes for short-term use (<24 hours) in adults (Model 4060) and infants (Model 4610).
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/K990112 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990112: Disposable Ecg Monitoring Electrodes, Models 4060, 4610.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990112
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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