510(k) · Cleared
ClearedADAM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Astro-Med, Inc. · GWQ Full-Montage Standard Electroencephalograph
Cleared on Feb 18, 2004 as substantially equivalent to K992291 (Grass-Telefactor Product Group, 1999) and 2 other predicates after a 57-day review. Its family tree reaches back 4 generations to 1989. 6 later devices descend from it.
- Decided
- Feb 18, 2004
- Review
- 57 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K884937 (1989). 7 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK884937 Beehive-64 or Beehive-32, Digital Eeg RecordingGrass-Telefactor Product Group · 1989
- 3 generations backK972202 Deeg-LiteGrass-Telefactor Product Group · 1997
- 2 generations backK974587 H2OGrass-Telefactor Product Group · 1998
- 1 generation backK992291 H20- Tethered OptionGrass-Telefactor Product Group · 1999
- This deviceK033978 ADAMAstro-Med, Inc. · 2004
- Descendant · cites it directly · 5 of its ownK050425 Aura-PSGAstro-Med, Inc. · 2005
- Descendant · 2 generations on · 4 of its ownK071782 Micromed Brain Spy Plus, Embia Titanium DevicesMicromed S.P.A. · 2008
- Descendant · 3 generations on · 3 of its ownK122196 Cervello Bio-Potential Signal Acquistion System Product FamilyBlackrock Neuromed, LLC · 2013
- Descendant · 4 generations on · 1 of its ownK133995 Neuron-Spectrum-4/P with Neuron-Spectrum.Net SoftwareNeurosoft, Ltd. · 2015
- Descendant · 5 generations on · 0 of its ownK220254 Neuron-Spectrum-AM with Neuron-Spectrum.NET SoftwareNeurosoft, Ltd. · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K050425Aura-PSGAstro-Med, Inc. · 2005 · cites it directly5descendants
- K071782Micromed Brain Spy Plus, Embia Titanium DevicesMicromed S.P.A. · 2008 · 2 generations on4descendants
- K122196Cervello Bio-Potential Signal Acquistion System Product FamilyBlackrock Neuromed, LLC · 2013 · 3 generations on3descendants
- K133995Neuron-Spectrum-4/P with Neuron-Spectrum.Net SoftwareNeurosoft, Ltd. · 2015 · 4 generations on1descendant
- K220254Neuron-Spectrum-AM with Neuron-Spectrum.NET SoftwareNeurosoft, Ltd. · 2022 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K884937 | Beehive-64 or Beehive-32, Digital Eeg Recording | Grass-Telefactor Product Group | 1989 | — |
| −3 | K972202 | Deeg-Lite | Grass-Telefactor Product Group | 1997 | — |
| −2 | K974587 | H2O | Grass-Telefactor Product Group | 1998 | — |
| −1 | K992291 | H20- Tethered Option | Grass-Telefactor Product Group | 1999 | — |
| 0 (this device) | K033978 | ADAM | Astro-Med, Inc. | 2004 | — |
| +1 | K050425 | Aura-PSG | Astro-Med, Inc. | 2005 | — |
| +2 | K071782 | Micromed Brain Spy Plus, Embia Titanium Devices | Micromed S.P.A. | 2008 | — |
| +3 | K122196 | Cervello Bio-Potential Signal Acquistion System Product Family | Blackrock Neuromed, LLC | 2013 | — |
| +4 | K133995 | Neuron-Spectrum-4/P with Neuron-Spectrum.Net Software | Neurosoft, Ltd. | 2015 | — |
| +5 | K220254 | Neuron-Spectrum-AM with Neuron-Spectrum.NET Software | Neurosoft, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K992291 | H20- Tethered OptionSummary page 1…NE Product Code: GWQ Product Class: Class 1IDevice This device claims substantial equivalence to the following: Telefactor H20: 510(k) numbers K992291 and K974587 Grass - Telefactor AS-40 Amplifier System 510(k) number K021807 Intended Use: The ADAM amplifier system is i… | 1999 |
| * | K974587 | H2OSummary page 1…Code: GWQ Product Class: Class 1IDevice This device claims substantial equivalence to the following: Telefactor H20: 510(k) numbers K992291 and K974587 Grass - Telefactor AS-40 Amplifier System 510(k) number K021807 Intended Use: The ADAM amplifier system is intended for… | 1998 |
| * | K021807 | Grass-Telefactor AS40 Amplifier SystemSummary page 1…claims substantial equivalence to the following: Telefactor H20: 510(k) numbers K992291 and K974587 Grass - Telefactor AS-40 Amplifier System 510(k) number K021807 Intended Use: The ADAM amplifier system is intended for recording routine EEG and EEG associated with long term monitoring for… | 2002 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050425 | Aura-PSG | 2005 | 5 |
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 15 years and passes through 2 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K050425 (Astro-Med, Inc., 2005) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K992291.
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 ADAM amplifier system is intended for recording routine EEG and EEG associated with long term monitoring for epilepsy.
This device is intended to be used only by physicians, technicians, or other medical professionals that are trained in electroencephalography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033978 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033978: ADAM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033978
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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