510(k) Report

510(k) · Cleared

Cleared

Ceegraph, Modification

K933233510(k) TraditionalCleared Mar 3, 1994316-day reviewClass II21 CFR 882.1400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bio-Logic Systems Corp. · GWQ Full-Montage Standard Electroencephalograph

Cleared on Mar 3, 1994 after a 316-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 14 devices in its family, counting itself, has a Class I recall. 13 later devices descend from it.

Decided
Mar 3, 1994
Review
316 days
Class
Class II
Product code
GWQ
Recalls
None
Predicates
0

13 later devices descend from it, 1 citing it directly. 1 of the 14 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1998: 1 descendant cleared2000: 1 descendant cleared2001: 1 descendant cleared2007: 1 descendant cleared2004: 1 descendant cleared2005: 1 descendant cleared2012: 1 descendant cleared2008: 1 descendant cleared2014: 1 descendant cleared, 1 with a Class I recall12018: 1 descendant cleared2013: 1 descendant cleared2015: 1 descendant cleared2022: 1 descendant cleared1990200020102020
  1. This deviceK933233 Ceegraph, ModificationBio-Logic Systems Corp. · 1994
  2. Descendant · cites it directly · 12 of its ownK973883 Bio-Logic Ceegraph 128-Channel Recording SystemBio-Logic Systems Corp. · 1998
  3. Descendant · 2 generations on · 6 of its ownK994142 Grass TS3201/6401 Eeg Amplifier SystemGrass Instrument Co. · 2000
  4. Descendant · 3 generations on · 5 of its ownK050425 Aura-PSGAstro-Med, Inc. · 2005
  5. Descendant · 4 generations on · 4 of its ownK071782 Micromed Brain Spy Plus, Embia Titanium DevicesMicromed S.P.A. · 2008
  6. Descendant · 2 generations on · 4 of its ownK012079 Geodesic Eeg System, Model 200Electrical Geodesics, Incorporated · 2001

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

1998: 12000: 12001: 12004: 12005: 12007: 12008: 12012: 12013: 12014: 12015: 12018: 12022: 1
1998high 1 (1998) · low 0 (1999)2026

Class I recalls in this family

Most influential descendants

Showing 5 of 13 · See all
  • K973883Bio-Logic Ceegraph 128-Channel Recording SystemBio-Logic Systems Corp. · 1998 · cites it directly12descendants
  • K994142Grass TS3201/6401 Eeg Amplifier SystemGrass Instrument Co. · 2000 · 2 generations on6descendants
  • K050425Aura-PSGAstro-Med, Inc. · 2005 · 3 generations on5descendants
  • K071782Micromed Brain Spy Plus, Embia Titanium DevicesMicromed S.P.A. · 2008 · 4 generations on4descendants
  • K012079Geodesic Eeg System, Model 200Electrical Geodesics, Incorporated · 2001 · 2 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K933233Ceegraph, ModificationBio-Logic Systems Corp.1994—
+1K973883Bio-Logic Ceegraph 128-Channel Recording SystemBio-Logic Systems Corp.1998—
+2K994142Grass TS3201/6401 Eeg Amplifier SystemGrass Instrument Co.2000—
+3K050425Aura-PSGAstro-Med, Inc.2005—
+4K071782Micromed Brain Spy Plus, Embia Titanium DevicesMicromed S.P.A.2008—
+2K012079Geodesic Eeg System, Model 200Electrical Geodesics, Incorporated2001—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200010
200110
200410
200510
200710
200810
201210
201310
201411
201510
201810
202210
FIG. 1 — Lineage of K933233, 1994–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. 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. #1 K260455 New Wave Systemscore 13.7 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (13)

See all 13

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K973883Bio-Logic Ceegraph 128-Channel Recording SystemBio-Logic Systems Corp.199812

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K131882Geodesiceeg System 400 Series (Ges 400)Electrical Geodesics, Inc. · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K973883 (Bio-Logic Systems Corp., 1998) has gone furthest, with 12 descendants of its own.

How does its category compare?

All GWQ devices

GWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GWQ

1in 2024

2007: 12008: 22010: 32011: 42012: 42013: 22014: 22015: 32016: 32017: 52018: 82020: 62022: 32023: 62024: 12026 (partial year): 2
2007high 8 (2018) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GWQ

137in 2023

2010: 73 days median2011: 220 days median2012: 208 days median2015: 276 days median2016: 50 days median2017: 181 days median2018: 150 days median2020: 216 days median2022: 216 days median2023: 137 days median
2007high 276 (2015) · low 50 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GWQ

1in 2020

2007: 52008: 22009: 12010: 12015: 22019: 22020: 12026 (partial year): 1
2007high 5 (2007) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GWQ

13in 2025

2007: 112008: 82009: 72010: 122011: 62012: 92013: 42014: 72015: 132016: 282017: 172018: 152019: 162020: 302021: 202022: 162023: 202024: 172025: 13
2007high 30 (2020) · low 4 (2013)2025

MAUDE reports naming product code GWQ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—511
20082—28
20090—17
2010373112
2011422006
2012420809
20132—04
20142—07
20153276213
2016350028
20175181017
20188150015
20190—216
20206216130
20210—020
20223216016
20236137020
20241—017
20250—013
20262—1—
Cite this page

510(k) Report. “K933233: Ceegraph, Modification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K933233

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026