510(k) · Cleared
ClearedNeonatal Ecg Electrode, M203KEN
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
R & D Medical Products, Inc. · DRX Electrode, Electrocardiograph
Cleared on Dec 10, 2009 as substantially equivalent to K050443 (Kentec Medical, Inc., 2005) and 1 other predicate after a 93-day review. Its family tree reaches back 2 generations to 2002. 26 later devices descend from it.
- Decided
- Dec 10, 2009
- Review
- 93 days
- Class
- Class II
- Product code
- DRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K011564 (2002). 26 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK011564 NeoleadNeotech Products, Inc. · 2002
- 1 generation backK050443 Accu-LeadKentec Medical, Inc. · 2005
- This deviceK092744 Neonatal Ecg Electrode, M203KENR & D Medical Products, Inc. · 2009
- Descendant · cites it directly · 24 of its ownK132694 Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014
- Descendant · 2 generations on · 23 of its ownK141968 Nuvasive NVM5 SystemNuvasive, Inc. · 2014
- Descendant · 3 generations on · 22 of its ownK143641 NuVasive NVM5 SystemNu Vasive, Incorporated · 2015 · Recalled
- Descendant · 4 generations on · 13 of its ownK152942 NuVasiveNVM5 SystemNu Vasive, Incorporated · 2016
- Descendant · 5 generations on · 7 of its ownK162313 NuVasive Next Generation NVM5 SystemNu Vasive, Incorporated · 2017
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K132694Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014 · cites it directly24descendants
- K141968Nuvasive NVM5 SystemNuvasive, Inc. · 2014 · 2 generations on23descendants
- K143641NuVasive NVM5 SystemNu Vasive, Incorporated · 2015 · 3 generations on22descendants
- K152942NuVasiveNVM5 SystemNu Vasive, Incorporated · 2016 · 4 generations on13descendants
- K162313NuVasive Next Generation NVM5 SystemNu Vasive, Incorporated · 2017 · 5 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011564 | Neolead | Neotech Products, Inc. | 2002 | — |
| −1 | K050443 | Accu-Lead | Kentec Medical, Inc. | 2005 | — |
| 0 (this device) | K092744 | Neonatal Ecg Electrode, M203KEN | R & D Medical Products, Inc. | 2009 | — |
| +1 | K132694 | Nuvasive NVM5 System | Nu Vasive, Incorporated | 2014 | — |
| +2 | K141968 | Nuvasive NVM5 System | Nuvasive, Inc. | 2014 | — |
| +3 | K143641 | NuVasive NVM5 System | Nu Vasive, Incorporated | 2015 | 1 |
| +4 | K152942 | NuVasiveNVM5 System | Nu Vasive, Incorporated | 2016 | — |
| +5 | K162313 | NuVasive Next Generation NVM5 System | Nu Vasive, Incorporated | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K050443 | Accu-LeadSummary page 1…: . Electrocardiographic electrode, 21 C.F.R. § 870.2360 Regulatory Class: Class II Product Code:. DRX Predicate Devices: K050443 - Ameritus Accu-Lead of Kentec Medical, Inc. KO 11564 - Neolead of Neotech Products, hic. Description… | 2005 |
| * | K011564 | Neolead | 2002 |
What descends from it? (26)
See all 262 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K132694 (Nu Vasive, Incorporated, 2014) has gone furthest, with 24 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. 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?
These electrodes are to be used in the neonatal or pediatric unit of hospitals for the resting ECG monitoring of newborn and premature birth infants. They are applied to the surface of the body, single use only, and disposable. These electrodes should be changed every 24 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092744 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092744: Neonatal Ecg Electrode, M203KEN.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092744
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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