510(k) · Cleared
Recalled · Class II · 2026Micromed BRAIN QUICK system
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micromed S.P.A. · GWQ Full-Montage Standard Electroencephalograph
Cleared on Feb 1, 2018 as substantially equivalent to K122196 (Blackrock Neuromed, LLC, 2013) and 1 other predicate after a 266-day review. Its family tree reaches back 8 generations to 1989. It has been recalled once.
- Decided
- Feb 1, 2018
- Review
- 266 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 8 generations to K884937 (1989). 29 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK884937 Beehive-64 or Beehive-32, Digital Eeg RecordingGrass-Telefactor Product Group · 1989
- 7 generations backK972202 Deeg-LiteGrass-Telefactor Product Group · 1997
- 6 generations backK974587 H2OGrass-Telefactor Product Group · 1998
- 5 generations backK992291 H20- Tethered OptionGrass-Telefactor Product Group · 1999
- 4 generations backK994142 Grass TS3201/6401 Eeg Amplifier SystemGrass Instrument Co. · 2000
- 3 generations backK050425 Aura-PSGAstro-Med, Inc. · 2005
- 2 generations backK071782 Micromed Brain Spy Plus, Embia Titanium DevicesMicromed S.P.A. · 2008
- 1 generation backK122196 Cervello Bio-Potential Signal Acquistion System Product FamilyBlackrock Neuromed, LLC · 2013
- This deviceK171384 Micromed BRAIN QUICK systemMicromed S.P.A. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K884937 | Beehive-64 or Beehive-32, Digital Eeg Recording | Grass-Telefactor Product Group | 1989 | — |
| −7 | K972202 | Deeg-Lite | Grass-Telefactor Product Group | 1997 | — |
| −6 | K974587 | H2O | Grass-Telefactor Product Group | 1998 | — |
| −5 | K992291 | H20- Tethered Option | Grass-Telefactor Product Group | 1999 | — |
| −4 | K994142 | Grass TS3201/6401 Eeg Amplifier System | Grass Instrument Co. | 2000 | — |
| −3 | K050425 | Aura-PSG | Astro-Med, Inc. | 2005 | — |
| −2 | K071782 | Micromed Brain Spy Plus, Embia Titanium Devices | Micromed S.P.A. | 2008 | — |
| −1 | K122196 | Cervello Bio-Potential Signal Acquistion System Product Family | Blackrock Neuromed, LLC | 2013 | — |
| 0 (this device) | K171384 | Micromed BRAIN QUICK system | Micromed S.P.A. | 2018 | — |
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 |
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? (2)
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 |
|---|---|---|---|
| * | K122196 | Cervello Bio-Potential Signal Acquistion System Product FamilySummary page 4…graph (21 CFR 882.1400) Regulatory Class: II Product Code: GWQ, OLV PREDICATE DEVICE The predicate devices used in this submission are: • K122196 Blackrock NeuroMed Cervello Bio-Potential Signal Acquisition System–Basic • K071782 MICROMED MORPHEUS, MICROMED BRAIN… | 2013 |
| * | K071782 | Micromed Brain Spy Plus, Embia Titanium DevicesSummary page 4…PREDICATE DEVICE The predicate devices used in this submission are: • K122196 Blackrock NeuroMed Cervello Bio-Potential Signal Acquisition System–Basic • K071782 MICROMED MORPHEUS, MICROMED BRAIN SPY PLUS DEVICE DESCRIPTION The Micromed BRAIN QUICK System is a multi-modal physiological rec… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 4, 2026 | Class II | Z-2353-2026 | Software Design Change | 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 5 companies; a new generation was cleared every 4.8 years on median.
- 2 of the 29 ancestors have a recall of any class.
- 1 other device also cites its predicate K122196.
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Micromed BRAIN QUICK system is intended to acquire and store physiological signals for EEG and/or polysomnography (PSG) and to transfer data to separate PSG analysis software. The system includes: -hardware recorders intended to acquire and temporarily store physiological signals for EEG and/or PSG and to transfer the data to separate polysomnographic analysis software, and -software which is used for the signal acquisition, display, storage, process…
Read the full statement (179 words)
The Micromed BRAIN QUICK system is intended to acquire and store physiological signals for EEG and/or polysomnography (PSG) and to transfer data to separate PSG analysis software.
The system includes:
-hardware recorders intended to acquire and temporarily store physiological signals for EEG and/or PSG and to transfer the data to separate polysomnographic analysis software, and
-software which is used for the signal acquisition, display, storage, process and measure of biologic signals.
The hardware recorders (amplifiers) are BRAIN SPY PLUS, MORPHEUS, SD LTM 32 EXPRESS and SD LTM 64 EXPRESS. They are intended to acquire the same kind of signals by using the SystemPlus EVOLUTION software. The recorder models differ based on the number of available EEG channels (16 in the BRAIN SPY PLUS, 24 in the MORPHEUS, 32 in SD LTM 32 EXPRESS and 64 in SD LTM 64 EXPRESS). A system with up to 256 channel can be obtained by cascading 4 SD LTM 64 EXPRESS amplifiers.
The device is intended to be used by physicians, technicians, and other medical professions that are trained in EEG and/or PSG.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171384 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171384: Micromed BRAIN QUICK system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171384
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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