510(k) · Cleared
ClearedNC-Stat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurometrix, Inc. · JXE Device, Nerve Conduction Velocity Measurement
Cleared on Jan 17, 2001 after a 64-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 21 later devices descend from it.
- Decided
- Jan 17, 2001
- Review
- 64 days
- Class
- Class II
- Product code
- JXE
- Recalls
- None
- Predicates
- 0
21 later devices descend from it, 3 citing it directly.
- This deviceK003508 NC-StatNeurometrix, Inc. · 2001
- Descendant · cites it directly · 20 of its ownK013459 Modification of NC-StatNeurometrix, Inc. · 2002
- Descendant · cites it directly · 19 of its ownK041320 Modification to NC-StatNeurometrix, Inc. · 2004
- Descendant · cites it directly · 18 of its ownK060584 NC-StatNeurometrix, Inc. · 2006
- Descendant · 2 generations on · 15 of its ownK070109 Neurometrix AdvanceNeurometrix, Inc. · 2008
- Descendant · 3 generations on · 12 of its ownK120979 Carefusion Nicolet EdxCarefusion 209, Inc. · 2012
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K013459Modification of NC-StatNeurometrix, Inc. · 2002 · cites it directly20descendants
- K041320Modification to NC-StatNeurometrix, Inc. · 2004 · cites it directly19descendants
- K060584NC-StatNeurometrix, Inc. · 2006 · cites it directly18descendants
- K070109Neurometrix AdvanceNeurometrix, Inc. · 2008 · 2 generations on15descendants
- K120979Carefusion Nicolet EdxCarefusion 209, Inc. · 2012 · 3 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003508 | NC-Stat | Neurometrix, Inc. | 2001 | — |
| +1 | K013459 | Modification of NC-Stat | Neurometrix, Inc. | 2002 | — |
| +1 | K041320 | Modification to NC-Stat | Neurometrix, Inc. | 2004 | — |
| +1 | K060584 | NC-Stat | Neurometrix, Inc. | 2006 | — |
| +2 | K070109 | Neurometrix Advance | Neurometrix, Inc. | 2008 | — |
| +3 | K120979 | Carefusion Nicolet Edx | Carefusion 209, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JXE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JXE device
- #1 K240189 NM-01/CPT neurometer (NM-01/CPT)score 10.9 · 7 generations · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (21)
See all 213 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, K013459 (Neurometrix, Inc., 2002) has gone furthest, with 20 descendants of its own.
How does its category compare?
All JXE devicesJXE Device, Nerve Conduction Velocity Measurement: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JXE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JXE
Too few JXE 510(k)s in any year since 2007 to give a median.
Recalls per year · JXE
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JXE
1in 2025
MAUDE reports naming product code JXE, 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 | 0 | — | 0 | 2 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 1 | 6 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K003508 · printed Nov 3, 2026
Cite this page
510(k) Report. “K003508: NC-Stat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K003508
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026