510(k) · Cleared
ClearedXltek Polysomnography Headbox, Model # PSG-40
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Excel Tech., Ltd. · OLV Standard Polysomnograph With Electroencephalograph
Cleared on Jul 12, 1999 after a 38-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Jul 12, 1999
- Review
- 38 days
- Class
- Class II
- Product code
- OLV
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK991900 Xltek Polysomnography Headbox, Model # PSG-40Excel Tech., Ltd. · 1999
- Descendant · cites it directly · 1 of its ownK062533 Bwii Eeg Digital, Model PV 1652; Bwii PSG Digital, Model PV 1524Neurovirtual USA, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK112107 Bwiii Eeg, Bwiii Eeg Plus, Bwiii PSG, Bwiii PSG PlusNeurovirtual USA, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK022037 Xltek Sleep SystemExcel Tech., Ltd. · 2002
Most influential descendants
Showing 3 of 3 · See all- K062533Bwii Eeg Digital, Model PV 1652; Bwii PSG Digital, Model PV 1524Neurovirtual USA, Inc. · 2006 · cites it directly1descendant
- K112107Bwiii Eeg, Bwiii Eeg Plus, Bwiii PSG, Bwiii PSG PlusNeurovirtual USA, Inc. · 2011 · cites it directly0descendants
- K022037Xltek Sleep SystemExcel Tech., Ltd. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991900 | Xltek Polysomnography Headbox, Model # PSG-40 | Excel Tech., Ltd. | 1999 | — |
| +1 | K062533 | Bwii Eeg Digital, Model PV 1652; Bwii PSG Digital, Model PV 1524 | Neurovirtual USA, Inc. | 2006 | — |
| +1 | K112107 | Bwiii Eeg, Bwiii Eeg Plus, Bwiii PSG, Bwiii PSG Plus | Neurovirtual USA, Inc. | 2011 | — |
| +1 | K022037 | Xltek Sleep System | Excel Tech., Ltd. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
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 OLV? 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 OLV device
- #1 K241288 Noxturnal Webscore 17.3 · 10 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? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
What does this lineage say?
- Of its descendants, K062533 (Neurovirtual USA, Inc., 2006) has gone furthest, with 1 descendant of its own.
How does its category compare?
All OLV devicesOLV Standard Polysomnograph With Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OLV
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLV
141in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLV
No recall names OLV since 2007.
Adverse event reports per year · OLV
1in 2025
MAUDE reports naming product code OLV, 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 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 3 | 83 | 0 | 0 |
| 2018 | 3 | 141 | 0 | 3 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 2 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The XLTek PSG-40 may be used for sleep recordings (polysomnography) in research or clinical environments for: o Digital recording of high-level output signals (such as EEG, respiratory and oximetry signals) from conventional polygraphic recorders, signal transducers or amplifiers e Selection of recorded signal sections for on-screen review, annotation annd marking of sleep stages Computer-assisted event marking and quantitative analysis of EEG…
Read the full statement (174 words)
The XLTek PSG-40 may be used for sleep recordings (polysomnography) in research or clinical environments for:
o Digital recording of high-level output signals (such as EEG, respiratory and oximetry signals) from conventional polygraphic recorders, signal transducers or amplifiers
e Selection of recorded signal sections for on-screen review, annotation annd 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 PSG-40 is not intended to replace conventional devices or methods used for sleep monitoring in critical care or intra-operative settings.
The PSG-40 requires competent user input, and its output must be reviewed and interpreted by trained polysomnographers or neurologists who will exercise professional judgement in using this information.
The PSG-40 does not make any judgement of normality or abnormality of the displayed signals or the results 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/K991900 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991900: Xltek Polysomnography Headbox, Model # PSG-40.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991900
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026