FDA product code · Neurology
GWQFull-Montage Standard Electroencephalograph
Product code GWQ covers Full-Montage Standard Electroencephalograph, a Class II device regulated under 21 CFR 882.1400. FDA has cleared 189 devices in this code, 2 of them in the last 12 months. Median review time across the 189 most recent decisions is 107 days. openFDA lists 23 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 882.1400
- Review panel
- Neurology
- Clearances
- 189
What is happening in GWQ right now?
GWQ (Full-Montage Standard Electroencephalograph) has one finding. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-2353-2026).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2353-2026 |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
What does product code GWQ cover?
GWQ is FDA's product code for Full-Montage Standard Electroencephalograph, a Class II device regulated under 21 CFR 882.1400.
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
Source: openFDA device/classification · record GWQ · retrieved
How many devices has FDA cleared in GWQ?
FDA has cleared 189 devices under product code GWQ since the 510(k) programme began in 1976, 2 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261604 | Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) | Neuroelectrics Barcelona S.L.U. | |
| K260455 | New Wave System | Zeto, Inc. | |
| K233403 | Flexset System | Zeto, Inc. | |
| K231366 | Neuronaute Plus | Bioserenity Sas | |
| K221959 | Q21 | Neurofield, Inc. | |
| K231457 | SPARK Scan | Spark Neuro, Inc. | |
| K221963 | Cumulus Functional Neurophysiology Platform | Cumulus Neuroscience Limited | |
| K230073 | Okti | Compumedics Limited | |
| K223644 | Neuronaute with IceCap 2 & IceCap 2 Small | Bioserenity | |
| K220056 | iSyncWave | iMediSync, Inc. |
How long does FDA review take for GWQ?
The median FDA review time for GWQ is 107 days, measured across the 189 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in GWQ?
openFDA lists 23 recall records against product code GWQ. A recall record covers one firm's corrective action and may span many device lots.
Z-2353-2026Open, ClassifiedMicromed S.p.A.
Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acquired from two or four different amplifiers used in a multiple amplifier configuration (128 or 256 channels) running firmware version 2022.02 were displayed with a shift of 1 second between the 64channels blocks. In rare circumstances, a fixed 1-second temporal delay may appear between two 64-channel modules with firmware 2021.02, 2022.01 or 2022.02 in a multi-module SEEG configuration, potentially leading to misinterpretation of results.
Z-2138-2025Open, ClassifiedNatus Neurology Incorporated
Natus received two complaints of left side labeling show impedance for right side.
Z-3143-2024Open, ClassifiedSEER MEDICAL PTY LTD
During CAPA investigations of sight production inconsistencies, it was highlighted that previous Electromagnetic Compatibility (EMC) assessments related to RF radiated emissions may not be reasonably equivalent to the current product due to design changes in the system. A new CAPA was opened to investigate the radiated emissions compliance issues. - Seer Home Systems distributed and retained in the field were not compliant with Electromagnetic Compatibility (EMC) testing according to IEC 60601-1-2 - Seer Home Systems, including accessories, were manufactured and distributed without application of proper design change and manufacturing controls - Seer Home Systems were distributed with labeling deficiencies
Z-1942-2024Open, ClassifiedWAVi Co.
Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due to the closing of their research study.
Z-0865-2021Open, ClassifiedNihon Kohden America Inc
Medical device non-conformance to electrical safety standard (IEC 60601-1).
Showing the 5 most recently initiated of 23. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for GWQ?
MAUDE holds 54 adverse-event reports naming product code GWQ, 17 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in GWQ unusual?
GWQ does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history |
23 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike.
What are the predicate devices in GWQ?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in GWQ?
Across the 189 most recent decisions, these applicants filed most often in GWQ.
| Applicant | Recent clearances |
|---|---|
| Excel Tech. , Ltd. | 15 |
| Nihon Kohden America, Inc. | 15 |
| Del Mar Avionics | 7 |
| Oxford Medilog, Inc. | 6 |
| Bio-Logic Systems Corp. | 5 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in GWQ files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Natus Medical Incorporated | 6 | 3 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch GWQ
Get an email the morning anything changes in GWQ — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.