# K042223: Xltek Connex IP Headbox, Model 1054

- Pathway: 510(k) (Special)
- Applicant: Excel Tech., Ltd.
- Decided: Sep 16, 2004 after 30 days
- Product code: OMB (Automatic Event Detection Software For Full-Montage Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- 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 Connex Headbox works in conjunction with Excel Tech Sleep software. This Connex headbox is used to acquire and review sleep recordings (polysomnography) in research or clinical environments for: • Digital recording of high-level output signals (such as EEG, respiratory and oximetry signals) from conventional polygraphic recorders, signal transducers or amplifiers. • Selection of recorded signal sections for on-screen review, annotation and marking of sleep stages. • Computer-assisted event marking and quantitative analysis of EEG, respiratory and oximetry signals. • Computer-assisted reporting of simple measures obtained from the recorded signals (such as magnitude, time and frequency and simple statistical measures of marked events) The Connex is not intended to replace conventional devices or methods used for sleep monitoring in critical care or intraoperative settings. The Connex requires competent user input, and its output must be reviewed and interpreted by trained polysomnographers or trained medical professionals who will exercise professional judgment in using this information. The Connex does not make any judgment of normality or abnormality of the displayed signals or the result of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.

Source page: https://510kreport.com/device/K042223
Methodology: https://510kreport.com/methodology