510(k) · Cleared
ClearedSYNAMPS2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuroscan · GWQ Full-Montage Standard Electroencephalograph
Cleared on Feb 6, 2003 as substantially equivalent to K001324 (Neuro Scan Labs, 2000) after an 86-day review. Its family tree reaches back 1 generation to 2000. 4 later devices descend from it.
- Decided
- Feb 6, 2003
- Review
- 86 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001324 (2000). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK001324 Synamps (32-64 Channels), Esi Synamps (65-128 Channels), Esi Synamps…Neuro Scan Labs · 2000
- This deviceK023771 SYNAMPS2Neuroscan · 2003
- Descendant · cites it directly · 2 of its ownK081151 Compumedics NeuvoCompumedics USA, Ltd. · 2008
- Descendant · 2 generations on · 1 of its ownK093223 Compumedics Grael System, Models: Grael, Grael EcgCompumedics Limited · 2010
- Descendant · 3 generations on · 0 of its ownK230073 OktiCompumedics Limited · 2023
- Descendant · cites it directly · 0 of its ownK042364 Panbus Digital Eeg & Sleep Acquisition DevicesLamont Medical, Inc. · 2004
Most influential descendants
Showing 4 of 4 · See all- K081151Compumedics NeuvoCompumedics USA, Ltd. · 2008 · cites it directly2descendants
- K093223Compumedics Grael System, Models: Grael, Grael EcgCompumedics Limited · 2010 · 2 generations on1descendant
- K230073OktiCompumedics Limited · 2023 · 3 generations on0descendants
- K042364Panbus Digital Eeg & Sleep Acquisition DevicesLamont Medical, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001324 | Synamps (32-64 Channels), Esi Synamps (65-128 Channels), Esi Synamps (129-256… | Neuro Scan Labs | 2000 | — |
| 0 (this device) | K023771 | SYNAMPS2 | Neuroscan | 2003 | — |
| +1 | K081151 | Compumedics Neuvo | Compumedics USA, Ltd. | 2008 | — |
| +2 | K093223 | Compumedics Grael System, Models: Grael, Grael Ecg | Compumedics Limited | 2010 | — |
| +3 | K230073 | Okti | Compumedics Limited | 2023 | — |
| +1 | K042364 | Panbus Digital Eeg & Sleep Acquisition Devices | Lamont Medical, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K001324 | Synamps (32-64 Channels), Esi Synamps (65-128 Channels), Esi Synamps (129-256 Channels) | 2000 |
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?
- Its one ancestor has no recall.
- Of its descendants, K081151 (Compumedics USA, Ltd., 2008) has gone furthest, with 2 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 | — |
What is it indicated for?
The Neuroscan SynAmps2 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 qualifiedtrained EEG technologists andor physicians. The data acquired must be interpreted by qualified physicians.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023771 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023771: SYNAMPS2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023771
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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