510(k) · Cleared
Recalled · Class II · 2021Natus Sleepworks, Model 104017
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Excel-Tech Ltd. (Xltek) · OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Cleared on Apr 19, 2011 after an 804-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it. It has been recalled once.
- Decided
- Apr 19, 2011
- Review
- 804 days
- Class
- Class II
- Product code
- OLZ
- Recalls
- 1
- Predicates
- 0
8 later devices descend from it, 4 citing it directly.
- This deviceK090277 Natus Sleepworks, Model 104017Excel-Tech Ltd. (Xltek) · 2011
- Descendant · cites it directly · 3 of its ownK173366 NicoletOneNatus Neurology Incorporated · 2018
- Descendant · 2 generations on · 1 of its ownK200878 Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · 2020
- Descendant · cites it directly · 1 of its ownK153353 Sandman EliteEmbla Systems · 2016
- Descendant · 3 generations on · 0 of its ownK251881 HippoMind (v1.0)Hippoclinic · 2025
- Descendant · 2 generations on · 0 of its ownK190760 Cadwell Bolt SoftwareCadwell Industries, Inc. · 2019
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K173366NicoletOneNatus Neurology Incorporated · 2018 · cites it directly3descendants
- K200878Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · 2020 · 2 generations on1descendant
- K153353Sandman EliteEmbla Systems · 2016 · cites it directly1descendant
- K251881HippoMind (v1.0)Hippoclinic · 2025 · 3 generations on0descendants
- K190760Cadwell Bolt SoftwareCadwell Industries, Inc. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K090277 | Natus Sleepworks, Model 104017 | Excel-Tech Ltd. (Xltek) | 2011 | — |
| +1 | K173366 | NicoletOne | Natus Neurology Incorporated | 2018 | — |
| +2 | K200878 | Natus NeuroWorks | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2020 | — |
| +1 | K153353 | Sandman Elite | Embla Systems | 2016 | — |
| +3 | K251881 | HippoMind (v1.0) | Hippoclinic | 2025 | — |
| +2 | K190760 | Cadwell Bolt Software | Cadwell Industries, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2025 | 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 OLZ? 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 OLZ device
- #1 K253390 Somnum (Somnum)score 14.3 · 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? (8)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 2, 2021 | Class II | Z-0661-2022 | Process change control | Tile kits that allow one to install and situate a video camera within a patient environment are not fitting properly in some domestic institution ceiling tile grids that have a thinner style grid frame. The ceiling tile may suddenly fall… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K173366 (Natus Neurology Incorporated, 2018) has gone furthest, with 3 descendants of its own.
How does its category compare?
All OLZ devicesOLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · OLZ
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLZ
185in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLZ
No recall names OLZ since 2007.
Adverse event reports per year · OLZ
3in 2025
MAUDE reports naming product code OLZ, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 3 | 122 | 0 | 1 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 2 | — | 0 | 1 |
| 2024 | 2 | — | 0 | 2 |
| 2025 | 4 | 185 | 0 | 3 |
| 2026 | 3 | 155 | 0 | — |
What is it indicated for?
The Sleepworks software works in conjunction with Connex, Trex or Netlink amplifiers intended for polysomnography studies. The software allows recording, displaying, analysis, printing and storage of physiological signals to assist in the diagnosis of various sleep disorders and sleep related respiratory disorders. The Sleepwdrks allows: " Automated analysis of physiological signals that is intended for use only in adults. " Ani optional Audio / visual…
Read the full statement (159 words)
The Sleepworks software works in conjunction with Connex, Trex or Netlink amplifiers intended for polysomnography studies. The software allows recording, displaying, analysis, printing and storage of physiological signals to assist in the diagnosis of various sleep disorders and sleep related respiratory disorders.
The Sleepwdrks allows:
" Automated analysis of physiological signals that is intended for use only in adults.
" Ani optional Audio / visual alert for user defined threshold onl calibrated DC input. These alerts are not intended for use as life support such as vital signs monitoring or continuous medical surveillance inl intensive care units.
" Sleep report templates are provided which summarize recorded and scored sleep data using simple measures including count, average, maximum and minimum values as welt as data ranges for trendled values;
Sleep Works software does not provide any diagnostic conclusion about the patient's condition and is intended to be used only by qualified and trained medical practitioners. in research and clinical environments.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K090277 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090277: Natus Sleepworks, Model 104017.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090277
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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