FDA product code GWQ: Full-Montage Standard Electroencephalograph
GWQ is the FDA product code for full-montage standard electroencephalograph. It is a Class II device, regulated under 21 CFR 882.1400 and reviewed by the Neurology panel. FDA has cleared 189 510(k) submissions under GWQ, 12 in the last five years, from 95 different applicants. The average 510(k) review took 144 days (median 107); 120 days on average over the last three years. FDA has posted 23 recalls for GWQ devices, 4 initiated in the last five years.
Definition
Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations
Classification
| Field | Value |
|---|---|
| Device name | Full-Montage Standard Electroencephalograph |
| Device class | Class II |
| Regulation | 21 CFR 882.1400 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for GWQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 5 | 203 |
| 2018 | 8 | 160 |
| 2020 | 6 | 229 |
| 2022 | 3 | 216 |
| 2023 | 6 | 176 |
| 2024 | 1 | 209 |
| 2026 | 2 | 30 |
Compare with all 510(k) review times · Search every GWQ clearance
Top GWQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nihon Kohden America, Inc. | 15 | 2012-03-22 |
| Excel Tech. , Ltd. | 15 | 2006-04-21 |
| Del Mar Avionics | 7 | 1986-03-27 |
| Oxford Medilog, Inc. | 6 | 1991-04-10 |
| Bio-Logic Systems Corp. | 5 | 2000-09-14 |
90 more applicants have GWQ clearances. See the full list in Caduvo.
Most recent GWQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261604 | Neuroelectrics Barcelona S.L.U. | Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) | 2026-06-13 | 30 |
| K260455 | Zeto, Inc. | New Wave System | 2026-03-13 | 30 |
| K233403 | Zeto, Inc. | Flexset System | 2024-04-30 | 209 |
| K231366 | Bioserenity Sas | Neuronaute Plus | 2023-11-09 | 182 |
| K221959 | Neurofield, Inc. | Q21 | 2023-08-31 | 422 |
Recalls for GWQ devices
23 product recalls in 21 recall events; 4 initiated in the last five years and 5 still open. Most recent: 2026-05-04.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 2 |
| 2020 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code GWQ?
GWQ is the FDA product code for full-montage standard electroencephalograph. It is a Class II device, regulated under 21 CFR 882.1400 and reviewed by the Neurology panel.
What device class is GWQ?
Class II, regulation 21 CFR 882.1400. Typical premarket route: 510(k).
How long does a 510(k) take for product code GWQ?
Across 189 cleared submissions the average was 144 days from receipt to decision (median 107).
Which companies have the most GWQ clearances?
Nihon Kohden America, Inc. (15); Excel Tech. , Ltd. (15); Del Mar Avionics (7); Oxford Medilog, Inc. (6); Bio-Logic Systems Corp. (5).
Have GWQ devices been recalled?
Yes: 23 product recalls across 21 recall events; the most recent began 2026-05-04.
Next steps
- Run an FDA pathway report with predicate devices for product code GWQ
- Run a recall and safety report across every GWQ manufacturer
- Watch product code GWQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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