# K982359: NC-Stat

- Pathway: 510(k) (Traditional)
- Applicant: Neurometrix, Inc.
- Decided: Oct 2, 1998 after 88 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 K802637 (1980). 2 ancestors in all.
21 later devices descend from it; 3 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K853608: Neurometer, Neurotron, Inc. (1986) Summary page 1.
- K802637: Teca Model-10 Electromyograph, Teca, Inc. (1980) Summary page 1.

## Most influential descendants
- K013459: Modification of NC-Stat (2002), 20 descendants of its own
- K041320: Modification to NC-Stat (2004), 19 descendants of its own
- K060584: NC-Stat (2006), 18 descendants of its own
- K070109: Neurometrix Advance (2008), 15 descendants of its own
- K120979: Carefusion Nicolet Edx (2012), 12 descendants of its own

## Indications for use
The NearoMetrix NC-stat is intended to measure neuromusculus siguals that ace useful in diagnosing and evaluating systemic and entrapment neuropathius. The NC-stal i intended to be used as an adjunct to and not a replacement for conventional clectrodiagnostic measurements.

Source page: https://510kreport.com/device/K982359
Methodology: https://510kreport.com/methodology