# K041320: Modification to NC-Stat

- Pathway: 510(k) (Traditional)
- Applicant: Neurometrix, Inc.
- Decided: Aug 12, 2004 after 86 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: 3 generations back to K802637 (1980). 6 ancestors in all.
19 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982359: NC-Stat, Neurometrix, Inc. (1998) Summary page 1.
- K000565: Modification to NC-Stat, Neurometrix, Inc. (2000) Summary page 1.
- K003508: NC-Stat, Neurometrix, Inc. (2001) Summary page 1.
- K013459: Modification of NC-Stat, Neurometrix, Inc. (2002) Summary page 1.
- K802637: Teca Model-10 Electromyograph, Teca, Inc. (1980) Summary page 1.

## Most influential descendants
- 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
- K162199: Cascade IOMAX Intraoperative Monitor (2017), 7 descendants of its own
- K212166: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (2022), 5 descendants of its own

## Indications for use
The NeuroMetrix NC-stat is intended to measure neuromuscular signals that are useful in diagnosing and evaluating systemic and entrapment neuropathies.

Source page: https://510kreport.com/device/K041320
Methodology: https://510kreport.com/methodology