# K190536: Mediracer NCS

- Pathway: 510(k) (Traditional)
- Applicant: Mediracer OY
- Decided: Sep 25, 2019 after 205 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: 6 generations back to K802637 (1980). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070109: Neurometrix Advance, Neurometrix, Inc. (2008) Summary page 4.

## Most influential descendants
- K240189: NM-01/CPT neurometer (NM-01/CPT) (2025), 0 descendants of its own

## Indications for use
The Mediracer NCS is intended to measure sensory and motor nerve conduction from peripheral nerves. The measured data can be utilized in evaluating patients suspected of having focal neuropathies. The measured data must be used in the context of other patient information and must be reviewed and interpreted by a physician.

Source page: https://510kreport.com/device/K190536
Methodology: https://510kreport.com/methodology