510(k) · Cleared
ClearedEnobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuroelectrics Barcelona S.L.U. · GWQ Full-Montage Standard Electroencephalograph
Cleared on Jun 13, 2026 as substantially equivalent to K162681 (Neuroelectrics Barcelona S.L.U., 2017) after a 30-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Jun 13, 2026
- Review
- 30 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K001564 (2000). 15 ancestors in all, the oldest K964280 (1997). No later device cites it as a predicate yet.
- Root · 6 generations backK001564 Scan LT40 (40 Channels)Neuro Scan Labs · 2000
- 5 generations backK023536 NuampsNeuroscan · 2003
- 4 generations backK060803 G.UsbampG.Tec Medical Engineering GmbH · 2006
- 3 generations backK090957 Blackrock Neuroport Biopotential Signal Processing SystemI2s Micro Implantable Systems, LLC · 2009 · Recalled
- 2 generations backK103140 Nicolet Wireless EegCarefusion 209, Inc. · 2011 · Recalled
- 1 generation backK162681 Enobio Wireless EEGNeuroelectrics Barcelona S.L.U. · 2017
- This deviceK261604 Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio…Neuroelectrics Barcelona S.L.U. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001564 | Scan LT40 (40 Channels) | Neuro Scan Labs | 2000 | — |
| −5 | K023536 | Nuamps | Neuroscan | 2003 | — |
| −4 | K060803 | G.Usbamp | G.Tec Medical Engineering GmbH | 2006 | — |
| −3 | K090957 | Blackrock Neuroport Biopotential Signal Processing System | I2s Micro Implantable Systems, LLC | 2009 | 2 |
| −2 | K103140 | Nicolet Wireless Eeg | Carefusion 209, Inc. | 2011 | 1 |
| −1 | K162681 | Enobio Wireless EEG | Neuroelectrics Barcelona S.L.U. | 2017 | — |
| 0 (this device) | K261604 | Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) | Neuroelectrics Barcelona S.L.U. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 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 |
|---|---|---|---|
| * | K162681 | Enobio Wireless EEGSummary page 5…aph ● Regulation Number: 21 CFR 882.1400 ● Product Code(s): GWQ (primary), GWL, GXY Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) ● Predicate #: K162681 ● Predicate Trade Name (Primary Predicate is listed first): Enobio Wireless EEG ● Product Code: GWQ Full-Montage Electr… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 6 companies; a new generation was cleared every 3.3 years on median.
- 3 of the 15 ancestors have a recall of any class.
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Enobio Dx is a wireless, battery-operated, and portable electrophysiology sensor system for the recording of electroencephalograms (EEG). Enobio Dx is available in three different models capable of providing either 8, 20, or 32 channels respectively. Enobio are portable EEG monitoring devices of 8, 20, and 32 channels intended for use in clinical patient monitoring for use in hospitals and other medical environments. The Enobio is intended to acquire…
Read the full statement (131 words)
Enobio Dx is a wireless, battery-operated, and portable electrophysiology sensor system for the recording of electroencephalograms (EEG). Enobio Dx is available in three different models capable of providing either 8, 20, or 32 channels respectively. Enobio are portable EEG monitoring devices of 8, 20, and 32 channels intended for use in clinical patient monitoring for use in hospitals and other medical environments. The Enobio is intended to acquire, store, transmit and display electrophysiological signals as an aid in diagnostics. The system digitizes analogue EEG signals collected by a cap with electrodes and uses WiFi connectivity to transmit the EEG data to a dedicated host computer with the software. This device is intended to be used by trained health-care personnel. It is restricted to sale by or on order of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261604 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261604: Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261604
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026