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 Oct 2, 1998 as substantially equivalent to K853608 (Neurotron, Inc., 1986) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 1980. 21 later devices descend from it.
- Decided
- Oct 2, 1998
- Review
- 88 days
- Class
- Class II
- Product code
- JXE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K802637 (1980). 2 ancestors in all. 21 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK802637 Teca Model-10 ElectromyographTeca, Inc. · 1980
- This deviceK982359 NC-StatNeurometrix, Inc. · 1998
- 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 |
|---|---|---|---|---|---|
| −1 | K802637 | Teca Model-10 Electromyograph | Teca, Inc. | 1980 | — |
| 0 (this device) | K982359 | NC-Stat | Neurometrix, Inc. | 1998 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
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), 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? (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 |
|---|---|---|---|
| * | K853608 | NeurometerSummary page 1…ily Mcasurement Device 3. PREDICATE DEVICES The NeuraMetrix NC-stat is substantially equivalent to the following devices: . Ncurotron Neurometer Premarket Notification K853608 . TECA TD-10/TD-20 EMG Premarket Notification K802637 4. DEVICE DESCRIPTION The NC-stat consists of a hand-held, battcry-operat… | 1986 |
| * | K802637 | Teca Model-10 ElectromyographSummary page 1…Metrix NC-stat is substantially equivalent to the following devices: . Ncurotron Neurometer Premarket Notification K853608 . TECA TD-10/TD-20 EMG Premarket Notification K802637 4. DEVICE DESCRIPTION The NC-stat consists of a hand-held, battcry-operatcd monitor and a disposable sensar. The NC-stat measur… | 1980 |
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?
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 NearoMetrix NC-stat is intended to measure neuromusculus siguals that ace useful
in diagnosing and evaluating systemic and entrapment neuropathius. The NC-stal i
intended to be used as an adjunct to and not a replacement for conventional
clectrodiagnostic measurements.
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/K982359 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982359: NC-Stat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982359
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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