510(k) · Cleared
ClearedXltek Connex IP Headbox, Model 1054
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Excel Tech., Ltd. · OMB Automatic Event Detection Software For Full-Montage Electroencephalograph
Cleared on Sep 16, 2004 after a 30-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 16, 2004
- Review
- 30 days
- Class
- Class II
- Product code
- OMB
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OMB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OMB device
- #1 K240993 encevis (2.1)score 15.0 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All OMB devicesOMB Automatic Event Detection Software For Full-Montage Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OMB
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OMB
143in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OMB
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OMB
6in 2025
MAUDE reports naming product code OMB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 2 |
| 2015 | 3 | 233 | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 3 | 108 | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 1 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 4 |
| 2024 | 5 | 201 | 0 | 21 |
| 2025 | 5 | 143 | 0 | 6 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (192 words)
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.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K042223 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042223: Xltek Connex IP Headbox, Model 1054.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042223
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026