510(k) · Cleared
ClearedREMbrandt
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 Apr 11, 2017 as substantially equivalent to K090277 (Excel-Tech Ltd. (Xltek), 2011) and 1 other predicate after a 110-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Apr 11, 2017
- Review
- 110 days
- Class
- Class II
- Product code
- OLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K962865 (1996). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK962865 Rembrandt SystemAirsep Corp. · 1996
- This deviceK163617 REMbrandtEmbla Systems · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962865 | Rembrandt System | Airsep Corp. | 1996 | — |
| 0 (this device) | K163617 | REMbrandt | Embla Systems | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K090277 | Natus Sleepworks, Model 104017Summary page 4…Polysomnograph with Electroencephalograph Product code: OLZ Device Class: II Regulation Number: 21 CFR 882.1400 Predicate Device: Natus SleepWorks K090277 (primary), REMbrandt K962865 Description: 1. Overview REMbrandt Software The REMbrandt software consists of three applications… | 2011 |
| * | K962865 | Rembrandt SystemSummary page 4…with Electroencephalograph Product code: OLZ Device Class: II Regulation Number: 21 CFR 882.1400 Predicate Device: Natus SleepWorks K090277 (primary), REMbrandt K962865 Description: 1. Overview REMbrandt Software The REMbrandt software consists of three applications, DataLab, Analysis Manager a… | 1996 |
| † | K142988 | Sleepware G3 | 2015 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 3 other devices also cite its predicate K090277.
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. 2017, 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 REMbrandt software is intended for Polysomnography studies and 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 REMbrandt software allows: 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…
Read the full statement (144 words)
The REMbrandt software is intended for Polysomnography studies and 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 REMbrandt software allows:
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.
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;
The REMbrandt 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 summary.
https://510kreport.com/device/K163617 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163617: REMbrandt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163617
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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