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 Mar 16, 2015 as substantially equivalent to K040595 (Respironics, Inc., 2004) and 1 other predicate after a 151-day review. Its family tree reaches back 5 generations to 1987. 4 later devices descend from it.
- Decided
- Mar 16, 2015
- Review
- 151 days
- Class
- Class II
- Product code
- OLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K873535 (1987). 16 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK873535 Nicolet Expert Sleep/Wake Analysis SystemNicolet Biomedical Instruments · 1987
- 4 generations backK955841 Sleep System for Clinics & ResearchCompumedics Ptd, Ltd. · 1997
- 3 generations backK022506 Morpheus 1, Automated Sleep Study Scoring & Data Management SystemWidemed, Ltd. · 2003
- 2 generations backK083620 Somnolyzer 24X7The Siesta Group North America · 2009
- 1 generation backK131994 Somnolyzer 24X7Respironics, Inc. · 2013
- This deviceK142988 Sleepware G3Respironics, Inc. · 2015
- Descendant · cites it directly · 2 of its ownK202142 Sleepware G3Respironics, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK241960 DeepRESPNox Medical Ehf · 2025
- Descendant · cites it directly · 0 of its ownK250851 Hypnos (369054-200)Cadwell Industries, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK252330 DeepRESPNox Medical Ehf · 2025
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 |
|---|---|---|---|---|---|
| −5 | K873535 | Nicolet Expert Sleep/Wake Analysis System | Nicolet Biomedical Instruments | 1987 | — |
| −4 | K955841 | Sleep System for Clinics & Research | Compumedics Ptd, Ltd. | 1997 | — |
| −3 | K022506 | Morpheus 1, Automated Sleep Study Scoring & Data Management System | Widemed, Ltd. | 2003 | — |
| −2 | K083620 | Somnolyzer 24X7 | The Siesta Group North America | 2009 | — |
| −1 | K131994 | Somnolyzer 24X7 | Respironics, Inc. | 2013 | — |
| 0 (this device) | K142988 | Sleepware G3 | Respironics, Inc. | 2015 | — |
| +1 | K202142 | Sleepware G3 | Respironics, Inc. | 2020 | — |
| +2 | K241960 | DeepRESP | Nox Medical Ehf | 2025 | — |
| +1 | K250851 | Hypnos (369054-200) | Cadwell Industries, Inc. | 2025 | — |
| +3 | 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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K040595 | ALICE 5Summary page 4…Class: II Primary Product Code: OLZ Secondary Product Code: MNR, OLV III. Predicate Devices Alice Sleepware Software (K040595) Somnolyzer 24x7 (K131994) These predicates have not been subject to any design-related recalls. No reference devices w… | 2004 |
| * | K131994 | Somnolyzer 24X7Summary page 4…oduct Code: OLZ Secondary Product Code: MNR, OLV III. Predicate Devices Alice Sleepware Software (K040595) Somnolyzer 24x7 (K131994) These predicates have not been subject to any design-related recalls. No reference devices were used in this submission. Res… | 2013 |
What descends from it? (4)
2 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 28 years and passes through 5 companies; a new generation was cleared every 5.8 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K202142 (Respironics, Inc., 2020) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K040595.
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. 2015, 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 infant or adult patients in a clinical environment by or on the order of a physician.
The optional Somnolyzer Inside scoring package has the same intended use as Sleepware G3, but is indicated for use with adult patients only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142988 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142988: 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/K142988
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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