510(k) · Cleared
ClearedModification to:Brevio Nerve Conduction Test Instrument
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurotron Medical, Inc. · JXE Device, Nerve Conduction Velocity Measurement
Cleared on Aug 1, 2001 as substantially equivalent to K963208 (Neurotron Medical, 1997) and 1 other predicate after a 30-day review. Its family tree reaches back 1 generation to 1985. 1 later device descends from it.
- Decided
- Aug 1, 2001
- Review
- 30 days
- Class
- Class II
- Product code
- JXE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K843924 (1985). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK843924 Digital Electroneurometer S-100Neurotron, Inc. · 1985
- This deviceK012069 Modification to:Brevio Nerve Conduction Test InstrumentNeurotron Medical, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK061828 Lorenz Biotech Aptiva, Version 2.13Lorenz Biotech S.P.A. · 2007
Most influential descendants
Showing 1 of 1 · See all- K061828Lorenz Biotech Aptiva, Version 2.13Lorenz Biotech S.P.A. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K843924 | Digital Electroneurometer S-100 | Neurotron, Inc. | 1985 | — |
| 0 (this device) | K012069 | Modification to:Brevio Nerve Conduction Test Instrument | Neurotron Medical, Inc. | 2001 | — |
| +1 | K061828 | Lorenz Biotech Aptiva, Version 2.13 | Lorenz Biotech S.P.A. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 |
|---|---|---|---|
| * | K963208 | Nervepace (R) Nerve Conduction Viewscope (200VS)Summary page 1…cal, Inc. 1590 Reed Rd., Suite 102B Pennington, NJ 08534 800-367-1238 Contact: Jack Guldalian, President Prepared: June 29, 2001 A. LEGALLY MARKETED PREDICATE DEVICES K963208 NervePace Nerve Conduction Viewscope (VS 200) Neurotron Medical, Inc. ' K843924 Digital Electroneurometer (S-100) Neurotron Medi… | 1997 |
| * | K843924 | Digital Electroneurometer S-100Summary page 1…ack Guldalian, President Prepared: June 29, 2001 A. LEGALLY MARKETED PREDICATE DEVICES K963208 NervePace Nerve Conduction Viewscope (VS 200) Neurotron Medical, Inc. ' K843924 Digital Electroneurometer (S-100) Neurotron Medical, Inc. B. DEVICE DESCRIPTION The BREVIO is a battery powered (4 AA batteries… | 1985 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061828 | Lorenz Biotech Aptiva, Version 2.13 | 2007 | 0 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K061828 (Lorenz Biotech S.P.A., 2007) has gone furthest, with 0 descendants 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 | — |
What is it indicated for?
The BREVIO is intended to be used as a waveform display nerve conduction monitor. It displays the latency value derived from an action potential. The display shows the latency value in milliseconds from the trigger to the onset. The internal circuitry has the complete waveform from which the latency value is derived and this is delivered to the digital storage oscilloscope for compete waveform display.
The latency value is important in the diagnosis of median nerve dysfunction. The physician can use the BREVIO to examine the features of the waveform generated by the stimuli. The physician can determine the action potential latency, amplitude configuration and duration.
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/K012069 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012069: Modification to:Brevio Nerve Conduction Test Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012069
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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