510(k) · Cleared
ClearedCervello Bio-Potential Signal Acquistion System Product Family
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blackrock Neuromed, LLC · GWQ Full-Montage Standard Electroencephalograph
Cleared on May 2, 2013 as substantially equivalent to K090957 (I2s Micro Implantable Systems, LLC, 2009) and 2 other predicates after a 282-day review. Its family tree reaches back 7 generations to 1989. 3 later devices descend from it.
- Decided
- May 2, 2013
- Review
- 282 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K884937 (1989). 28 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK884937 Beehive-64 or Beehive-32, Digital Eeg RecordingGrass-Telefactor Product Group · 1989
- 6 generations backK972202 Deeg-LiteGrass-Telefactor Product Group · 1997
- 5 generations backK974587 H2OGrass-Telefactor Product Group · 1998
- 4 generations backK992291 H20- Tethered OptionGrass-Telefactor Product Group · 1999
- 3 generations backK994142 Grass TS3201/6401 Eeg Amplifier SystemGrass Instrument Co. · 2000
- 2 generations backK050425 Aura-PSGAstro-Med, Inc. · 2005
- 1 generation backK071782 Micromed Brain Spy Plus, Embia Titanium DevicesMicromed S.P.A. · 2008
- This deviceK122196 Cervello Bio-Potential Signal Acquistion System Product FamilyBlackrock Neuromed, LLC · 2013
- Descendant · cites it directly · 1 of its ownK133995 Neuron-Spectrum-4/P with Neuron-Spectrum.Net SoftwareNeurosoft, Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK220254 Neuron-Spectrum-AM with Neuron-Spectrum.NET SoftwareNeurosoft, Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK171384 Micromed BRAIN QUICK systemMicromed S.P.A. · 2018 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K133995Neuron-Spectrum-4/P with Neuron-Spectrum.Net SoftwareNeurosoft, Ltd. · 2015 · cites it directly1descendant
- K220254Neuron-Spectrum-AM with Neuron-Spectrum.NET SoftwareNeurosoft, Ltd. · 2022 · 2 generations on0descendants
- K171384Micromed BRAIN QUICK systemMicromed S.P.A. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K884937 | Beehive-64 or Beehive-32, Digital Eeg Recording | Grass-Telefactor Product Group | 1989 | — |
| −6 | K972202 | Deeg-Lite | Grass-Telefactor Product Group | 1997 | — |
| −5 | K974587 | H2O | Grass-Telefactor Product Group | 1998 | — |
| −4 | K992291 | H20- Tethered Option | Grass-Telefactor Product Group | 1999 | — |
| −3 | K994142 | Grass TS3201/6401 Eeg Amplifier System | Grass Instrument Co. | 2000 | — |
| −2 | K050425 | Aura-PSG | Astro-Med, Inc. | 2005 | — |
| −1 | K071782 | Micromed Brain Spy Plus, Embia Titanium Devices | Micromed S.P.A. | 2008 | — |
| 0 (this device) | K122196 | Cervello Bio-Potential Signal Acquistion System Product Family | Blackrock Neuromed, LLC | 2013 | — |
| +1 | K133995 | Neuron-Spectrum-4/P with Neuron-Spectrum.Net Software | Neurosoft, Ltd. | 2015 | — |
| +2 | K220254 | Neuron-Spectrum-AM with Neuron-Spectrum.NET Software | Neurosoft, Ltd. | 2022 | — |
| +1 | K171384 | Micromed BRAIN QUICK system | Micromed S.P.A. | 2018 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 6 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 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? (3)
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 |
|---|---|---|---|
| * | K090957 | Blackrock Neuroport Biopotential Signal Processing SystemSummary page 2…Page 2 of 13 I BLACKROCK NEUPOMED 5 10(k) Number: K090957 Manufacture: 12S Micro Implantable Systems, LLC d/b/a Blackrock Microsystems Tra… | 2009 |
| * | K071782 | Micromed Brain Spy Plus, Embia Titanium DevicesSummary page 2…ignal Processing System Product Code: GWL Classification: 882.1835 5 10O(k) Number: K07 1782 Manufacture: Micromed SP.A. Trade Name: Micromed Brain Spy Plus, M… | 2008 |
| * | K000963 | DA Vinchi Eeg and Emg/EP SystemsSummary page 2…Embla Titanium Devices Product Code: GWQ Classification: 866.3740 5 10(k) Number: K000963 Manufacture: Airsep Corp. (Marketed by Embla) Trade Name: Da Vinch… | 2000 |
What descends from it? (3)
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?
- The line of descent spans 24 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 28 ancestors have a recall of any class.
- Of its descendants, K133995 (Neurosoft, Ltd., 2015) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K090957.
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Blackrock NeuroMed Cervello Bio-Potential Signal Acquisition Product Family contains the following configurations: Ambulatory Up to 64 channels with one Cervello hardware device (Amplifier) using the Cervello software. The device is intended to acquire and store physiological signals for EEG and/or PSG, and to transfer the data to separate polysomnographic analysis software. The devices are intended to be used by physicians, technicians and other…
Read the full statement (333 words)
The Blackrock NeuroMed Cervello Bio-Potential Signal Acquisition Product Family contains the following configurations:
Ambulatory
Up to 64 channels with one Cervello hardware device (Amplifier) using the Cervello software. The device is intended to acquire and store physiological signals for EEG and/or PSG, and to transfer the data to separate polysomnographic analysis software. The devices are intended to be used by physicians, technicians and other medical professions that are trained in EEG and/or PSG.
The Cervello Ambulatory System does not make any judgment of normality or abnormality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.
Basic
Up to 64 channels with one Cervello hardware device (Amplifier) and up to 128 channels by cascading 2 Cervello devices using the Cervello software. The device is intended to acquire and store physiological signals for EEG and/or PSC, and to transfer the data to separate polysomnographic analysis software. The devices are intended to be used by physicians, technicians and other medical professions that are trained in EEC and/or PSG.
The Cervello Basic System does not make any judgment of normality or abnormality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.
Elite
Up to 128 with one Neuroport Bio-Potential Recording Systems and up to 256 by cascading two Neuroport systems using the Central and/or Cervello software. The system supports recording, processing and display of bio-potential signals from user-supplied electrodes. Bio-potential signals include: Electrocorticography (ECoC), electroencephalography (EEC), electromyography (EMC), electrocardiography (ECG), electrooculography (EOG) and Evoked Potential (EP). Intended users include Physicians, technicians, clinicians or other medical professionals that are trained in bio-potential and/or EEC recording.
The Cervello Elite System does not make any judgment of normality or abnormality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.
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/K122196 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122196: Cervello Bio-Potential Signal Acquistion System Product Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122196
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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