# K240189: NM-01/CPT neurometer (NM-01/CPT)

- Pathway: 510(k) (Traditional)
- Applicant: Mde Orvosbiológiai Kutató, Fejleszto,
- Decided: Mar 26, 2025 after 427 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: 7 generations back to K802637 (1980). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K843924: Digital Electroneurometer S-100, Neurotron, Inc. (1985) Summary page 5.
- K190536: Mediracer NCS, Mediracer OY (2019) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K240189
Methodology: https://510kreport.com/methodology