510(k) · Cleared
ClearedXltek Sleep System
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 Sep 10, 2002 as substantially equivalent to K991900 (Excel Tech., Ltd., 1999) and 3 other predicates after a 78-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Sep 10, 2002
- Review
- 78 days
- Class
- Class II
- Product code
- OLV
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K962603 (1997). 11 ancestors in all, the oldest K923682 (1992). No later device cites it as a predicate yet.
- Root · 4 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 3 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 2 generations backK990966 Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp. · 1999
- 1 generation backK992340 Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop…Masimo Corp. · 1999 · Recalled
- This deviceK022037 Xltek Sleep SystemExcel Tech., Ltd. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −3 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −2 | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable… | Masimo Corp. | 1999 | — |
| −1 | K992340 | Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop… | Masimo Corp. | 1999 | 1 |
| 0 (this device) | K022037 | Xltek Sleep System | Excel Tech., Ltd. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K991900 | Xltek Polysomnography Headbox, Model # PSG-40Summary page 2…S FEIKC @i, SPECIAL 510(k) DEVICE MODIFICATION JUNE 17, 2002 PAGE 50 of 53 Substantial Equivalence: The SLEEP Headbox is substantially equivalent to the XLTEK PSG-40 (K991900) incorporating Masimo pulse oximetry technology (K992340/K0000126). It comprises circuitry that is substantially equivalent to th… | 1999 |
| * | K992340 | Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop -Adt-Adult/Pediatric…Summary page 1…5S1 (905) 829-5300 (905) 829-5304 [email protected] Sleep Headbox Electroencephalograph XLTEK PSG-40 Polysomnography Headbox K9991900 Masimo Radical Pulse Oximeter K992340/K000126 XLTEK Ambulatory EEG K982479 The SLEEP Headbox is a digital polysomnograph headbox used in conjunction with XLTEK SLEEP… | 1999 |
| * | K000126 | Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop-Adt-Adult/Pediatric…Summary page 1…05) 829-5300 (905) 829-5304 [email protected] Sleep Headbox Electroencephalograph XLTEK PSG-40 Polysomnography Headbox K9991900 Masimo Radical Pulse Oximeter K992340/K000126 XLTEK Ambulatory EEG K982479 The SLEEP Headbox is a digital polysomnograph headbox used in conjunction with XLTEK SLEEP Softwar… | 2000 |
| * | K982479 | Excel Ambulatory EegSummary page 1…[email protected] Sleep Headbox Electroencephalograph XLTEK PSG-40 Polysomnography Headbox K9991900 Masimo Radical Pulse Oximeter K992340/K000126 XLTEK Ambulatory EEG K982479 The SLEEP Headbox is a digital polysomnograph headbox used in conjunction with XLTEK SLEEP Software to acquire and review sleep… | 1998 |
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.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 11 ancestors has a recall of any class.
- 2 other devices also cite its predicate K991900.
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 Sleep Headbox works in conjunction with Excel Tech Sleep software. This Sleep System is used to acquire and review sleep recordings (polysomnography) in rescarch 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…
Read the full statement (190 words)
The Sleep Headbox works in conjunction with Excel Tech Sleep software. This Sleep System is used to acquire and review sleep recordings (polysomnography) in rescarch 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 measurcs obtained from the recorded signals (such as magnitude, time and frequency and simple statistical measures of marked events)
The SLEEP System is not intended to replace conventional devices or methods used for sleep monitoring in critical care or intraoperative settings.
The SLEEP System requires competent user input, and its output must be revicwed and interpreted by trained polysomnographers or trained medical professionals who will exercise professional judgment in using this information.
The SLEEP System 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 summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K022037 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022037: Xltek Sleep System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022037
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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