510(k) · Cleared
ClearedDigital Electroneurometer S-100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurotron, Inc. · JXE Device, Nerve Conduction Velocity Measurement
Cleared on Mar 12, 1985 after a 158-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Mar 12, 1985
- Review
- 158 days
- Class
- Class II
- Product code
- JXE
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK843924 Digital Electroneurometer S-100Neurotron, Inc. · 1985
- Descendant · cites it directly · 1 of its ownK012069 Modification to:Brevio Nerve Conduction Test InstrumentNeurotron Medical, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK240189 NM-01/CPT neurometer (NM-01/CPT)Mde Orvosbiológiai Kutató, Fejleszto, · 2025
- Descendant · 2 generations on · 0 of its ownK061828 Lorenz Biotech Aptiva, Version 2.13Lorenz Biotech S.P.A. · 2007
Most influential descendants
Showing 3 of 3 · See all- K012069Modification to:Brevio Nerve Conduction Test InstrumentNeurotron Medical, Inc. · 2001 · cites it directly1descendant
- K240189NM-01/CPT neurometer (NM-01/CPT)Mde Orvosbiológiai Kutató, Fejleszto, · 2025 · cites it directly0descendants
- K061828Lorenz Biotech Aptiva, Version 2.13Lorenz Biotech S.P.A. · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K843924 | Digital Electroneurometer S-100 | Neurotron, Inc. | 1985 | — |
| +1 | K012069 | Modification to:Brevio Nerve Conduction Test Instrument | Neurotron Medical, Inc. | 2001 | — |
| +1 | K240189 | NM-01/CPT neurometer (NM-01/CPT) | Mde Orvosbiológiai Kutató, Fejleszto, | 2025 | — |
| +2 | K061828 | Lorenz Biotech Aptiva, Version 2.13 | Lorenz Biotech S.P.A. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2007 | 1 | 0 |
| 2025 | 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? (3)
2 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, K012069 (Neurotron Medical, Inc., 2001) has gone furthest, with 1 descendant 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/K843924 · printed Nov 6, 2026
Cite this page
510(k) Report. “K843924: Digital Electroneurometer S-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K843924
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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