# K053058: Xltek Neuropath, Model PK1070

- Pathway: 510(k) (Traditional)
- Applicant: Excel Tech., Ltd.
- Decided: Feb 7, 2006 after 99 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The XLTEK NeuroPath is intended to stimulate and measure neuromuscular signals that are useful in diagnosing and evaluating systemic and entrapment neuropathies. The XLTEK NeuroPath is intended to be used as an adjunct to and not a replacement for conventional electrodiagnostic measurements.

Source page: https://510kreport.com/device/K053058
Methodology: https://510kreport.com/methodology