510(k) · Cleared
ClearedHypnos (369054-200)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cadwell Industries, Inc. · OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Cleared on Dec 14, 2025 as substantially equivalent to K142988 (Respironics, Inc., 2015) after a 268-day review. Its family tree reaches back 6 generations to 1987.
- Decided
- Dec 14, 2025
- Review
- 268 days
- Class
- Class II
- Product code
- OLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K873535 (1987). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK873535 Nicolet Expert Sleep/Wake Analysis SystemNicolet Biomedical Instruments · 1987
- 5 generations backK955841 Sleep System for Clinics & ResearchCompumedics Ptd, Ltd. · 1997
- 4 generations backK022506 Morpheus 1, Automated Sleep Study Scoring & Data Management SystemWidemed, Ltd. · 2003
- 3 generations backK083620 Somnolyzer 24X7The Siesta Group North America · 2009
- 2 generations backK131994 Somnolyzer 24X7Respironics, Inc. · 2013
- 1 generation backK142988 Sleepware G3Respironics, Inc. · 2015
- This deviceK250851 Hypnos (369054-200)Cadwell Industries, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K873535 | Nicolet Expert Sleep/Wake Analysis System | Nicolet Biomedical Instruments | 1987 | — |
| −5 | K955841 | Sleep System for Clinics & Research | Compumedics Ptd, Ltd. | 1997 | — |
| −4 | K022506 | Morpheus 1, Automated Sleep Study Scoring & Data Management System | Widemed, Ltd. | 2003 | — |
| −3 | K083620 | Somnolyzer 24X7 | The Siesta Group North America | 2009 | — |
| −2 | K131994 | Somnolyzer 24X7 | Respironics, Inc. | 2013 | — |
| −1 | K142988 | Sleepware G3 | Respironics, Inc. | 2015 | — |
| 0 (this device) | K250851 | Hypnos (369054-200) | Cadwell Industries, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 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? (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.
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 38 years and passes through 6 companies; a new generation was cleared every 6.2 years on median.
- 1 of the 17 ancestors has a recall of any class.
- 1 other device also cites its predicate K142988.
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. 2025, 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?
Cadwell Hypnos is a software application used for Polysomnography (PSG) and other clinical sleep studies. It is intended for use by research and clinical sleep professionals. It measures, records, displays, organizes, analyzes, summarizes, and retrieves physiological signals during sleep and wake used to assist in the assessment of sleep and the diagnosis of various sleep disorders including sleep related breathing disorders. The software can be used for…
Read the full statement (170 words)
Cadwell Hypnos is a software application used for Polysomnography (PSG) and other clinical sleep studies. It is intended for use by research and clinical sleep professionals. It measures, records, displays, organizes, analyzes, summarizes, and retrieves physiological signals during sleep and wake used to assist in the assessment of sleep and the diagnosis of various sleep disorders including sleep related breathing disorders. The software can be used for analysis (computer-assisted as well as manual scoring of events), display, retrieval, summarization, reporting and networking of data received from devices used to monitor sleep related parameters.
Hypnos is indicated for use in all sleep disorders patient populations from neonate to adult, including infants, pediatrics and geriatric populations. Computer-assisted analysis features of the application are only intended for use on adults.
Hypnos is only indicated for use by trained medical professionals for the purpose of assessing sleep disorders.
Intended environments include hospitals, institutions, sleep centers, sleep clinics, and other sleep disorders testing environments.
Hypnos is NOT intended to be used to perform automatic diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250851 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250851: Hypnos (369054-200).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250851
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