# K012069: Modification to:Brevio Nerve Conduction Test Instrument

- Pathway: 510(k) (Special)
- Applicant: Neurotron Medical, Inc.
- Decided: Aug 1, 2001 after 30 days
- Product code: JXE (Device, Nerve Conduction Velocity Measurement)
- Device class: 2
- Regulation: 21 CFR 882.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K843924 (1985). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963208: Nervepace (R) Nerve Conduction Viewscope (200VS), Neurotron Medical (1997) Summary page 1.
- K843924: Digital Electroneurometer S-100, Neurotron, Inc. (1985) Summary page 1.

## Most influential descendants
- K061828: Lorenz Biotech Aptiva, Version 2.13 (2007), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K012069
Methodology: https://510kreport.com/methodology