510(k) · Cleared
ClearedSleepware G3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Cleared on Oct 29, 2020 as substantially equivalent to K142988 (Respironics, Inc., 2015) after a 90-day review. Its family tree reaches back 6 generations to 1987. 2 later devices descend from it.
- Decided
- Oct 29, 2020
- Review
- 90 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. 2 later devices descend from it, 1 citing it directly.
- 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 deviceK202142 Sleepware G3Respironics, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK241960 DeepRESPNox Medical Ehf · 2025
- Descendant · 2 generations on · 0 of its ownK252330 DeepRESPNox Medical Ehf · 2025
Most influential descendants
Showing 2 of 2 · See allView 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) | K202142 | Sleepware G3 | Respironics, Inc. | 2020 | — |
| +1 | K241960 | DeepRESP | Nox Medical Ehf | 2025 | — |
| +2 | K252330 | DeepRESP | Nox Medical Ehf | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K142988 | Sleepware G3Summary page 4…omatic Event Detection Software for Polysomnograph with Electroencephalograph III. Legally Marketed Predicate Device • K142988 Sleepware G3, Respironics Inc. Page… | 2015 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241960 | DeepRESP | 2025 | 1 |
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 33 years and passes through 5 companies; a new generation was cleared every 5.8 years on median.
- 1 of the 17 ancestors has a recall of any class.
- Of its descendants, K241960 (Nox Medical Ehf, 2025) has gone furthest, with 1 descendant of its own.
- 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. 2020, 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?
Sleepware G3 is a software application used for analysis (automatic and manual scoring), display, retrieval, summarization, report generation, and networking of data received from monitoring devices used to categorize sleep related events that help aid in the diagnosis of sleep-related disorders. It is indicated for use with adults (18 and older) and infant patients (one year old or less) in a clinical environment by or on the order of a physician. The…
Read the full statement (127 words)
Sleepware G3 is a software application used for analysis (automatic and manual scoring), display, retrieval, summarization, report generation, and networking of data received from monitoring devices used to categorize sleep related events that help aid in the diagnosis of sleep-related disorders. It is indicated for use with adults (18 and older) and infant patients (one year old or less) in a clinical environment by or on the order of a physician.
The optional Somnolyzer scoring algorithms are for use with adults (18 and older) to generate an output that is ready for review and interpretation by a physician. Cardio-Respiratory Sleep Staging (CReSS) is an additional functionality of Somnolyzer which uses standard Home Sleep Apnea Test HSAT signals (in the absence of EEG signals) to infer sleep stage.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K202142 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202142: Sleepware G3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202142
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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