510(k) · Cleared
ClearedNox Sleep System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nox Medical · OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Cleared on Nov 13, 2019 as substantially equivalent to K072201 (Compumedics Limited, 2008) after a 65-day review. Its family tree reaches back 3 generations to 1987. 4 later devices descend from it.
- Decided
- Nov 13, 2019
- Review
- 65 days
- Class
- Class II
- Product code
- OLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K873535 (1987). 7 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK873535 Nicolet Expert Sleep/Wake Analysis SystemNicolet Biomedical Instruments · 1987
- 2 generations backK955841 Sleep System for Clinics & ResearchCompumedics Ptd, Ltd. · 1997
- 1 generation backK072201 Compumedics Somte PSG Recording SystemCompumedics Limited · 2008
- This deviceK192469 Nox Sleep SystemNox Medical · 2019
- Descendant · cites it directly · 1 of its ownK241960 DeepRESPNox Medical Ehf · 2025
- Descendant · cites it directly · 1 of its ownK223539 Dreem 3SBeacon Biosignals, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK252330 DeepRESPNox Medical Ehf · 2025
- Descendant · 2 generations on · 0 of its ownK242094 Dreem 3SBeacon Biosignals, Inc. · 2024
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K873535 | Nicolet Expert Sleep/Wake Analysis System | Nicolet Biomedical Instruments | 1987 | — |
| −2 | K955841 | Sleep System for Clinics & Research | Compumedics Ptd, Ltd. | 1997 | — |
| −1 | K072201 | Compumedics Somte PSG Recording System | Compumedics Limited | 2008 | — |
| 0 (this device) | K192469 | Nox Sleep System | Nox Medical | 2019 | — |
| +1 | K241960 | DeepRESP | Nox Medical Ehf | 2025 | — |
| +1 | K223539 | Dreem 3S | Beacon Biosignals, Inc. | 2023 | — |
| +1 | K252330 | DeepRESP | Nox Medical Ehf | 2025 | — |
| +2 | K242094 | Dreem 3S | Beacon Biosignals, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K072201 | Compumedics Somte PSG Recording SystemSummary page 4…Review Panel: Neurology Predicate Devices: Substantial equivalence is claimed to Compumedics Somté PSG System (K072201) from Compumedics Limited. The Nox T3 (K082113) from Nox Medical and Embletta… | 2008 |
| † | K082113 | Nox T3, Noxturnal (PC Application) | 2008 |
| † | K122516 | Embletta MPR | 2013 |
What descends from it? (4)
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?
- The line of descent spans 32 years and passes through 4 companies; a new generation was cleared every 11.1 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K241960 (Nox Medical Ehf, 2025) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K072201.
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. 2019, 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 Nox Sleep System is used as an aid in the diagnosis of different sleep disorders and for the assessment of sleep. The Nox Sleep System is used to measure, record, display, organize, analyze, summarize, and retrieve physiological parameters during sleep and wake. The Nox Sleep System allows the user to decide on the complexity of the study by varying the number and types of physiological signals measured. The Nox Sleep System allows for generation of…
Read the full statement (128 words)
The Nox Sleep System is used as an aid in the diagnosis of different sleep disorders and for the assessment of sleep.
The Nox Sleep System is used to measure, record, display, organize, analyze, summarize, and retrieve physiological parameters during sleep and wake.
The Nox Sleep System allows the user to decide on the complexity of the study by varying the number and types of physiological signals measured.
The Nox Sleep System allows for generation of user/pre-defined reports based on subject´s data.
The user of the Nox Sleep System are medical professionals who have received training in the areas of hospital/clinical procedures, physiological monitoring of human subjects, or sleep disorder investigation.
The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including patient's home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192469 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192469: Nox Sleep System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192469
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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