510(k) · Cleared
ClearedDeeg-Lite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Grass-Telefactor Product Group · GWQ Full-Montage Standard Electroencephalograph
Cleared on Jul 23, 1997 as substantially equivalent to K884937 (Grass-Telefactor Product Group, 1989) after a 42-day review. Its family tree reaches back 1 generation to 1989. 11 later devices descend from it.
- Decided
- Jul 23, 1997
- Review
- 42 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K884937 (1989). 11 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK884937 Beehive-64 or Beehive-32, Digital Eeg RecordingGrass-Telefactor Product Group · 1989
- This deviceK972202 Deeg-LiteGrass-Telefactor Product Group · 1997
- Descendant · cites it directly · 9 of its ownK974587 H2OGrass-Telefactor Product Group · 1998
- Descendant · 2 generations on · 8 of its ownK992291 H20- Tethered OptionGrass-Telefactor Product Group · 1999
- Descendant · 2 generations on · 6 of its ownK033978 ADAMAstro-Med, Inc. · 2004
- Descendant · 3 generations on · 6 of its ownK994142 Grass TS3201/6401 Eeg Amplifier SystemGrass Instrument Co. · 2000
- Descendant · 3 generations on · 5 of its ownK050425 Aura-PSGAstro-Med, Inc. · 2005
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K974587H2OGrass-Telefactor Product Group · 1998 · cites it directly9descendants
- K992291H20- Tethered OptionGrass-Telefactor Product Group · 1999 · 2 generations on8descendants
- K033978ADAMAstro-Med, Inc. · 2004 · 2 generations on6descendants
- K994142Grass TS3201/6401 Eeg Amplifier SystemGrass Instrument Co. · 2000 · 3 generations on6descendants
- K050425Aura-PSGAstro-Med, Inc. · 2005 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K884937 | Beehive-64 or Beehive-32, Digital Eeg Recording | Grass-Telefactor Product Group | 1989 | — |
| 0 (this device) | K972202 | Deeg-Lite | Grass-Telefactor Product Group | 1997 | — |
| +1 | K974587 | H2O | Grass-Telefactor Product Group | 1998 | — |
| +2 | K992291 | H20- Tethered Option | Grass-Telefactor Product Group | 1999 | — |
| +2 | K033978 | ADAM | Astro-Med, Inc. | 2004 | — |
| +3 | K994142 | Grass TS3201/6401 Eeg Amplifier System | Grass Instrument Co. | 2000 | — |
| +3 | K050425 | Aura-PSG | Astro-Med, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K884937 | Beehive-64 or Beehive-32, Digital Eeg RecordingSummary page 1…roduct class; Class H’ Device Tier: 2 £ This device claims equivalence to: Telefactor Corporation’s BEEHIVE- EEG-Recorder for which previously granted 510(k) number is: K884937. g. Brief functional description of the device: DEEG-LITE receives signals from an EEG Amplifier, formats & records them on the… | 1989 |
| † | K870450 | Szac-16 Seizure Analysis Computer | 1987 |
What descends from it? (11)
See all 112 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?
- Its one ancestor has no recall.
- Of its descendants, K974587 (Grass-Telefactor Product Group, 1998) has gone furthest, with 9 descendants of its own.
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?
This device is intended for use for long-term digital recording of voltages produced by the brain and measured on the scalp (EEG) for subsequent diagnostic review with a digital workstation supplied by the manufacturer (Telefactor Beekeeper) or similar compatible device.
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/K972202 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972202: Deeg-Lite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972202
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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