510(k) · Cleared
ClearedModification of NC-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, 2002 as substantially equivalent to K982359 (Neurometrix, Inc., 1998) and 3 other predicates after a 91-day review. Its family tree reaches back 2 generations to 1980. 20 later devices descend from it.
- Decided
- Jan 17, 2002
- Review
- 91 days
- Class
- Class II
- Product code
- JXE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K802637 (1980). 5 ancestors in all. 20 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK802637 Teca Model-10 ElectromyographTeca, Inc. · 1980
- 1 generation backK982359 NC-StatNeurometrix, Inc. · 1998
- This deviceK013459 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 · cites it directly · 15 of its ownK070109 Neurometrix AdvanceNeurometrix, Inc. · 2008
- Descendant · 2 generations on · 12 of its ownK120979 Carefusion Nicolet EdxCarefusion 209, Inc. · 2012
- Descendant · 3 generations on · 7 of its ownK162199 Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc. · 2017 · Recalled
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K041320Modification to NC-StatNeurometrix, Inc. · 2004 · cites it directly19descendants
- K060584NC-StatNeurometrix, Inc. · 2006 · cites it directly18descendants
- K070109Neurometrix AdvanceNeurometrix, Inc. · 2008 · cites it directly15descendants
- K120979Carefusion Nicolet EdxCarefusion 209, Inc. · 2012 · 2 generations on12descendants
- K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc. · 2017 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K802637 | Teca Model-10 Electromyograph | Teca, Inc. | 1980 | — |
| −1 | K982359 | NC-Stat | Neurometrix, Inc. | 1998 | — |
| 0 (this device) | K013459 | Modification of NC-Stat | Neurometrix, Inc. | 2002 | — |
| +1 | K041320 | Modification to NC-Stat | Neurometrix, Inc. | 2004 | — |
| +1 | K060584 | NC-Stat | Neurometrix, Inc. | 2006 | — |
| +1 | K070109 | Neurometrix Advance | Neurometrix, Inc. | 2008 | — |
| +2 | K120979 | Carefusion Nicolet Edx | Carefusion 209, Inc. | 2012 | — |
| +3 | K162199 | Cascade IOMAX Intraoperative Monitor | Cadwell Industries, Inc. | 2017 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 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? (4)
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 |
|---|---|---|---|
| * | K982359 | NC-StatSummary page 1…tary Name: NC-stat Common/Usual Name: Nerve Conduction Monitoring System Classification Name: Nerve Conduction Velocity Measuring Device 3. PREDICATE DEVICES e NC-stat (K982359, K000565 and K003508) ¢ TECA TD-10/TD-20 (K802637) 4. INTENDED USE The NeuroMetrix NC-stat is intended to measure neuromuscular… | 1998 |
| * | K000565 | Modification to NC-StatSummary page 1…: NC-stat Common/Usual Name: Nerve Conduction Monitoring System Classification Name: Nerve Conduction Velocity Measuring Device 3. PREDICATE DEVICES e NC-stat (K982359, K000565 and K003508) ¢ TECA TD-10/TD-20 (K802637) 4. INTENDED USE The NeuroMetrix NC-stat is intended to measure neuromuscular signals… | 2000 |
| * | K003508 | NC-StatSummary page 1…mmon/Usual Name: Nerve Conduction Monitoring System Classification Name: Nerve Conduction Velocity Measuring Device 3. PREDICATE DEVICES e NC-stat (K982359, K000565 and K003508) ¢ TECA TD-10/TD-20 (K802637) 4. INTENDED USE The NeuroMetrix NC-stat is intended to measure neuromuscular signals that are use… | 2001 |
| * | K802637 | Teca Model-10 ElectromyographSummary page 1…tion Monitoring System Classification Name: Nerve Conduction Velocity Measuring Device 3. PREDICATE DEVICES e NC-stat (K982359, K000565 and K003508) ¢ TECA TD-10/TD-20 (K802637) 4. INTENDED USE The NeuroMetrix NC-stat is intended to measure neuromuscular signals that are useful in diagnosing and evaluat… | 1980 |
What descends from it? (20)
See all 203 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 22 years and passes through 2 companies; a new generation was cleared every 17.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K041320 (Neurometrix, Inc., 2004) has gone furthest, with 19 descendants of its own.
- 2 other devices also cite its predicate K982359.
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 | — |
What is it indicated for?
The NeuroMetrix NC-stat is intended to measure neuromuscular signals that are useful in diagnosing and evaluating systemic and entrapment neuropathies.
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/K013459 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013459: Modification of NC-Stat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013459
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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