510(k) · Cleared
ClearedModification to 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 Aug 12, 2004 as substantially equivalent to K982359 (Neurometrix, Inc., 1998) and 4 other predicates after an 86-day review. Its family tree reaches back 3 generations to 1980. 19 later devices descend from it.
- Decided
- Aug 12, 2004
- Review
- 86 days
- Class
- Class II
- Product code
- JXE
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K802637 (1980). 6 ancestors in all. 19 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK802637 Teca Model-10 ElectromyographTeca, Inc. · 1980
- 2 generations backK982359 NC-StatNeurometrix, Inc. · 1998
- 1 generation backK013459 Modification of NC-StatNeurometrix, Inc. · 2002
- This deviceK041320 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
- Descendant · 4 generations on · 5 of its ownK212166 ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert…Inomed Medizintechnik GmbH · 2022
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- 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
- K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH · 2022 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K802637 | Teca Model-10 Electromyograph | Teca, Inc. | 1980 | — |
| −2 | K982359 | NC-Stat | Neurometrix, Inc. | 1998 | — |
| −1 | K013459 | Modification of NC-Stat | Neurometrix, Inc. | 2002 | — |
| 0 (this device) | 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 |
| +4 | K212166 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | Inomed Medizintechnik GmbH | 2022 | — |
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 |
|---|---|---|
| 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? (5)
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…Nerve Conduction Testing System Classification Name: Nerve Conduction Velocity Measuring Device 3. PREDICATE DEVICES * NC-stat (K982359, K000565, K003508 and K013459) * TECA TD-10/TD-20 (K802637) 4. INTENDED USE The NeuroMetrix NC-stat is i… | 1998 |
| * | K000565 | Modification to NC-StatSummary page 1…Nerve Conduction Testing System Classification Name: Nerve Conduction Velocity Measuring Device 3. PREDICATE DEVICES * NC-stat (K982359, K000565, K003508 and K013459) * TECA TD-10/TD-20 (K802637) 4. INTENDED USE The NeuroMetrix NC-stat is intended t… | 2000 |
| * | K003508 | NC-StatSummary page 1…nduction Testing System Classification Name: Nerve Conduction Velocity Measuring Device 3. PREDICATE DEVICES * NC-stat (K982359, K000565, K003508 and K013459) * TECA TD-10/TD-20 (K802637) 4. INTENDED USE The NeuroMetrix NC-stat is intended to measure… | 2001 |
| * | K013459 | Modification of NC-StatSummary page 1…ting System Classification Name: Nerve Conduction Velocity Measuring Device 3. PREDICATE DEVICES * NC-stat (K982359, K000565, K003508 and K013459) * TECA TD-10/TD-20 (K802637) 4. INTENDED USE The NeuroMetrix NC-stat is intended to measure neuromuscul… | 2002 |
| * | K802637 | Teca Model-10 ElectromyographSummary page 1…Nerve Conduction Velocity Measuring Device 3. PREDICATE DEVICES * NC-stat (K982359, K000565, K003508 and K013459) * TECA TD-10/TD-20 (K802637) 4. INTENDED USE The NeuroMetrix NC-stat is intended to measure neuromuscular signals that are useful in dia… | 1980 |
What descends from it? (19)
See all 192 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 24 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K060584 (Neurometrix, Inc., 2006) has gone furthest, with 18 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 as stated in the FDA summary.
https://510kreport.com/device/K041320 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041320: Modification to NC-Stat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041320
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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