510(k) · Cleared
ClearedNicolet Expert Sleep/Wake Analysis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nicolet Biomedical Instruments · GWQ Full-Montage Standard Electroencephalograph
Cleared on Oct 26, 1987 after a 55-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 65 later devices descend from it.
- Decided
- Oct 26, 1987
- Review
- 55 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 0
65 later devices descend from it, 2 citing it directly.
- This deviceK873535 Nicolet Expert Sleep/Wake Analysis SystemNicolet Biomedical Instruments · 1987
- Descendant · cites it directly · 63 of its ownK955841 Sleep System for Clinics & ResearchCompumedics Ptd, Ltd. · 1997
- Descendant · 2 generations on · 48 of its ownK072201 Compumedics Somte PSG Recording SystemCompumedics Limited · 2008
- Descendant · 3 generations on · 40 of its ownK111194 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2011
- Descendant · 2 generations on · 40 of its ownK072014 VitascoreVitascore B.V. · 2007
- Descendant · 3 generations on · 39 of its ownK082968 Apneicare Connection Center/Internet AnalysisApneicare, LLC · 2009
Showing 5 of 65 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 65 · See all- K955841Sleep System for Clinics & ResearchCompumedics Ptd, Ltd. · 1997 · cites it directly63descendants
- K072201Compumedics Somte PSG Recording SystemCompumedics Limited · 2008 · 2 generations on48descendants
- K111194Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2011 · 3 generations on40descendants
- K072014VitascoreVitascore B.V. · 2007 · 2 generations on40descendants
- K082968Apneicare Connection Center/Internet AnalysisApneicare, LLC · 2009 · 3 generations on39descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K873535 | Nicolet Expert Sleep/Wake Analysis System | Nicolet Biomedical Instruments | 1987 | — |
| +1 | K955841 | Sleep System for Clinics & Research | Compumedics Ptd, Ltd. | 1997 | — |
| +2 | K072201 | Compumedics Somte PSG Recording System | Compumedics Limited | 2008 | — |
| +3 | K111194 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2011 | — |
| +2 | K072014 | Vitascore | Vitascore B.V. | 2007 | — |
| +3 | K082968 | Apneicare Connection Center/Internet Analysis | Apneicare, LLC | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2003 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 0 |
| 2024 | 5 | 0 |
| 2025 | 4 | 0 |
| 2026 | 7 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GWQ? 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 GWQ device
- #1 K260455 New Wave Systemscore 13.7 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (65)
See all 652 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?
- Of its descendants, K955841 (Compumedics Ptd, Ltd., 1997) has gone furthest, with 63 descendants of its own.
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GWQ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GWQ
137in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWQ
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWQ
13in 2025
MAUDE reports naming product code GWQ, 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 | — | 5 | 11 |
| 2008 | 2 | — | 2 | 8 |
| 2009 | 0 | — | 1 | 7 |
| 2010 | 3 | 73 | 1 | 12 |
| 2011 | 4 | 220 | 0 | 6 |
| 2012 | 4 | 208 | 0 | 9 |
| 2013 | 2 | — | 0 | 4 |
| 2014 | 2 | — | 0 | 7 |
| 2015 | 3 | 276 | 2 | 13 |
| 2016 | 3 | 50 | 0 | 28 |
| 2017 | 5 | 181 | 0 | 17 |
| 2018 | 8 | 150 | 0 | 15 |
| 2019 | 0 | — | 2 | 16 |
| 2020 | 6 | 216 | 1 | 30 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 3 | 216 | 0 | 16 |
| 2023 | 6 | 137 | 0 | 20 |
| 2024 | 1 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 13 |
| 2026 | 2 | — | 1 | — |
https://510kreport.com/device/K873535 · printed Nov 6, 2026
Cite this page
510(k) Report. “K873535: Nicolet Expert Sleep/Wake Analysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K873535
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026