510(k) · Cleared
ClearedNeolead
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neotech Products, Inc. · DRX Electrode, Electrocardiograph
Cleared on Jan 3, 2002 after a 227-day review. The FDA summary names its predicate without a number. 30 later devices descend from it.
- Decided
- Jan 3, 2002
- Review
- 227 days
- Class
- Class II
- Product code
- DRX
- Recalls
- None
- Predicates
- 0
30 later devices descend from it, 4 citing it directly.
- This deviceK011564 NeoleadNeotech Products, Inc. · 2002
- Descendant · cites it directly · 27 of its ownK050443 Accu-LeadKentec Medical, Inc. · 2005
- Descendant · cites it directly · 26 of its ownK092744 Neonatal Ecg Electrode, M203KENR & D Medical Products, Inc. · 2009
- Descendant · 2 generations on · 24 of its ownK132694 Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014
- Descendant · 3 generations on · 23 of its ownK141968 Nuvasive NVM5 SystemNuvasive, Inc. · 2014
- Descendant · 4 generations on · 22 of its ownK143641 NuVasive NVM5 SystemNu Vasive, Incorporated · 2015 · Recalled
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K050443Accu-LeadKentec Medical, Inc. · 2005 · cites it directly27descendants
- K092744Neonatal Ecg Electrode, M203KENR & D Medical Products, Inc. · 2009 · cites it directly26descendants
- K132694Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014 · 2 generations on24descendants
- K141968Nuvasive NVM5 SystemNuvasive, Inc. · 2014 · 3 generations on23descendants
- K143641NuVasive NVM5 SystemNu Vasive, Incorporated · 2015 · 4 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011564 | Neolead | Neotech Products, Inc. | 2002 | — |
| +1 | K050443 | Accu-Lead | Kentec Medical, Inc. | 2005 | — |
| +1 | K092744 | Neonatal Ecg Electrode, M203KEN | R & D Medical Products, Inc. | 2009 | — |
| +2 | K132694 | Nuvasive NVM5 System | Nu Vasive, Incorporated | 2014 | — |
| +3 | K141968 | Nuvasive NVM5 System | Nuvasive, Inc. | 2014 | — |
| +4 | K143641 | NuVasive NVM5 System | Nu Vasive, Incorporated | 2015 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 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? (11)
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 |
|---|---|---|---|
| * | — | Kittycat-Kendall-LTP Named without a submission number | |
| * | — | Neotrode-ConMe Corp Named without a submission number | |
| * | — | Klear-Trace-CAS Medical Systems, Inc Named without a submission number | |
| * | — | SilveReez-Clinimark Named without a submission number | |
| * | — | H/P —HewlettPackard Named without a submission number | |
| * | — | NeoBar Named without a submission number | |
| * | — | NeoSmile Named without a submission number | |
| * | — | NeoBridge Named without a submission number | |
| * | — | NeoHold Named without a submission number | |
| * | — | NeoShades Named without a submission number | |
| * | — | NeoBond Named without a submission number |
What descends from it? (30)
See all 304 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?
- Of its descendants, K050443 (Kentec Medical, Inc., 2005) has gone furthest, with 27 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 NeoLead Hydrocolloid/ Hydrogel electrode is intended to be used
for resting ECG monitoring on neonatal and pediatric patients in a
hospital setting.
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/K011564 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011564: Neolead.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011564
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026