510(k) · Cleared
ClearedCompumedics Neuvo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Compumedics USA, Ltd. · GWQ Full-Montage Standard Electroencephalograph
Cleared on Sep 8, 2008 as substantially equivalent to K023771 (Neuroscan, 2003) after a 138-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it.
- Decided
- Sep 8, 2008
- Review
- 138 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001324 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK001324 Synamps (32-64 Channels), Esi Synamps (65-128 Channels), Esi Synamps…Neuro Scan Labs · 2000
- 1 generation backK023771 SYNAMPS2Neuroscan · 2003
- This deviceK081151 Compumedics NeuvoCompumedics USA, Ltd. · 2008
- Descendant · cites it directly · 1 of its ownK093223 Compumedics Grael System, Models: Grael, Grael EcgCompumedics Limited · 2010
- Descendant · 2 generations on · 0 of its ownK230073 OktiCompumedics Limited · 2023
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 |
|---|---|---|---|---|---|
| −2 | K001324 | Synamps (32-64 Channels), Esi Synamps (65-128 Channels), Esi Synamps (129-256… | Neuro Scan Labs | 2000 | — |
| −1 | K023771 | SYNAMPS2 | Neuroscan | 2003 | — |
| 0 (this device) | K081151 | Compumedics Neuvo | Compumedics USA, Ltd. | 2008 | — |
| +1 | K093223 | Compumedics Grael System, Models: Grael, Grael Ecg | Compumedics Limited | 2010 | — |
| +2 | K230073 | Okti | Compumedics Limited | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2023 | 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 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? (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 |
|---|---|---|---|
| * | K023771 | SYNAMPS2Summary page 1…graph (EEG) Classification Name: GWQ, GWP, GWF, GWE, GWJ Device Classification: ~ Class II: 21 CFR § 882.1400 Electroencephalograph Predicate Device: SynAmps2 510¢k) # K023771 Description of the Devicc: The Compumedics Ncuvo System is intcnded for measuring recording of the electrical activity of a pat… | 2003 |
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 |
|---|---|---|---|
| K093223 | Compumedics Grael System, Models: Grael, Grael Ecg | 2010 | 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 8 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K093223 (Compumedics Limited, 2010) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K023771.
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Compumedics Neuvo System is intended for measuring recording of the electrical activity of a patient’s brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. The system is intended for the EEG and long/middle/short-latency EP registration in the research environment. The system is intended to be used by qualified/trained EEG technologists and/or physicians. The data acquired must be interpreted by a qualified physician.
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/K081151 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081151: Compumedics Neuvo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081151
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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