510(k) · Cleared
ClearedSandman Elite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Embla Systems · OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Cleared on Jun 23, 2016 as substantially equivalent to K934599 (Melville Software, Ltd., 1994) and 1 other predicate after a 216-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Jun 23, 2016
- Review
- 216 days
- Class
- Class II
- Product code
- OLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K934599 (1994). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K182227Esprit NovaNeurozone Msh Incorporated · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934599 | Sandman | Melville Software, Ltd. | 1994 | — |
| 0 (this device) | K153353 | Sandman Elite | Embla Systems | 2016 | — |
| +1 | K182227 | Esprit Nova | Neurozone Msh Incorporated | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 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? (2)
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 |
|---|---|---|---|
| * | K934599 | SandmanSummary page 4…r Polysomnograph with Electroencephalograph Product code: OLZ Device Class: II Regulation Number: 21 CFR 882.1400 Predicate Device: Sandman (K934599); Natus SleepWorks (K090277) Description: 1. Overview Sandman Elite Software The Sandman Elite Application is a software produ… | 1994 |
| * | K090277 | Natus Sleepworks, Model 104017Summary page 4…somnograph with Electroencephalograph Product code: OLZ Device Class: II Regulation Number: 21 CFR 882.1400 Predicate Device: Sandman (K934599); Natus SleepWorks (K090277) Description: 1. Overview Sandman Elite Software The Sandman Elite Application is a software product that runs on a desktop or… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182227 | Esprit Nova | 2019 | 0 |
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?
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. 2016, 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 Sandman Elite software is intended for Polysomnography studies on pediatric and adult patients, and allows recording, displaying, analysis, printing and storage of physiological signals to assist in the diagnosis of various sleep disorders. The Sandman software also allows: •Sleep report templates which summarize recorded and scored sleep data using simple measures including count, average, maximum and minimum values as well as data ranges for…
Read the full statement (155 words)
The Sandman Elite software is intended for Polysomnography studies on pediatric and adult patients, and allows recording, displaying, analysis, printing and storage of physiological signals to assist in the diagnosis of various sleep disorders. The Sandman software also allows:
•Sleep report templates which summarize recorded and scored sleep data using simple measures including count, average, maximum and minimum values as well as data ranges for trended values;
•An optional automated analysis of physiological signals that is intended for use only in adults;
•An optional audio/visual alert for user defined threshold on calibrated DC input. These alerts are not intended for use as life support such as vital signs monitoring or continuous medical surveillance in intensive care units.
The Sandman software is intended for use only by qualified and trained medical practitioners in research and clinical environments, who evaluate the software output with their clinical experience and judgment to provide diagnostic conclusions about the patient's condition.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153353 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153353: Sandman Elite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153353
Report an extraction error
Are you the manufacturer?
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