510(k) · Cleared
ClearedNM-01/CPT neurometer (NM-01/CPT)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mde Orvosbiológiai Kutató, Fejleszto, · JXE Device, Nerve Conduction Velocity Measurement
Cleared on Mar 26, 2025 as substantially equivalent to K843924 (Neurotron, Inc., 1985) and 1 other predicate after a 427-day review. Its family tree reaches back 7 generations to 1980.
- Decided
- Mar 26, 2025
- Review
- 427 days
- Class
- Class II
- Product code
- JXE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K802637 (1980). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK802637 Teca Model-10 ElectromyographTeca, Inc. · 1980
- 6 generations backK982359 NC-StatNeurometrix, Inc. · 1998
- 5 generations backK013459 Modification of NC-StatNeurometrix, Inc. · 2002
- 4 generations backK041320 Modification to NC-StatNeurometrix, Inc. · 2004
- 3 generations backK060584 NC-StatNeurometrix, Inc. · 2006
- 2 generations backK070109 Neurometrix AdvanceNeurometrix, Inc. · 2008
- 1 generation backK190536 Mediracer NCSMediracer OY · 2019
- This deviceK240189 NM-01/CPT neurometer (NM-01/CPT)Mde Orvosbiológiai Kutató, Fejleszto, · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K802637 | Teca Model-10 Electromyograph | Teca, Inc. | 1980 | — |
| −6 | K982359 | NC-Stat | Neurometrix, Inc. | 1998 | — |
| −5 | K013459 | Modification of NC-Stat | Neurometrix, Inc. | 2002 | — |
| −4 | K041320 | Modification to NC-Stat | Neurometrix, Inc. | 2004 | — |
| −3 | K060584 | NC-Stat | Neurometrix, Inc. | 2006 | — |
| −2 | K070109 | Neurometrix Advance | Neurometrix, Inc. | 2008 | — |
| −1 | K190536 | Mediracer NCS | Mediracer OY | 2019 | — |
| 0 (this device) | K240189 | NM-01/CPT neurometer (NM-01/CPT) | Mde Orvosbiológiai Kutató, Fejleszto, | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K843924 | Digital Electroneurometer S-100Summary page 5…ice Device, Nerve Conduction Velocity Measurement 882.1550 JXE 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K843924 Digital Electroneurometer S-100 JXE K190536 Mediracer JXE Device Description Summary 21 CFR 807.92(a)(4) The NM-01/CPT neuromet… | 1985 |
| * | K190536 | Mediracer NCSSummary page 5…rement 882.1550 JXE 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K843924 Digital Electroneurometer S-100 JXE K190536 Mediracer JXE Device Description Summary 21 CFR 807.92(a)(4) The NM-01/CPT neurometer is a noninvasive device intended for veri… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 45 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 12 ancestors has a recall of any class.
- 1 other device also cites its predicate K843924.
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. 2025, this device’s year, is highlighted.
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 NM-01/CPT neurometer is a noninvasive electrodiagnostic device intended for verifying nerve integrity in conscious adult patients, with intact skin surface. The population of subject for whom this device may be used for diagnostic purposes would include any individual capable of communicating their perception of cutaneous sensation. The NM-01/CPT neurometer may be conducted as a part of a routine neurological examination. The measured data can be…
Read the full statement (114 words)
The NM-01/CPT neurometer is a noninvasive electrodiagnostic device intended for verifying nerve integrity in conscious adult patients, with intact skin surface.
The population of subject for whom this device may be used for diagnostic purposes would include any individual capable of communicating their perception of cutaneous sensation.
The NM-01/CPT neurometer may be conducted as a part of a routine neurological examination. The measured data can be utilized in evaluating patients suspected of having neuropathies. The measured data must be used in the context of other patient information and must be reviewed and interpreted by a physician. The device is intended for use on adults in medical clinics, healthcare practices and out-patient departments of hospitals.
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/K240189 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240189: NM-01/CPT neurometer (NM-01/CPT).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240189
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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