510(k) · Cleared
ClearedCeegraph Traveler Ambulatory Eeg Recorder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Logic Systems Corp. · GWQ Full-Montage Standard Electroencephalograph
Cleared on Jan 25, 1996 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 47 later devices descend from it.
- Decided
- Jan 25, 1996
- Review
- 87 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 0
47 later devices descend from it, 3 citing it directly.
- This deviceK954954 Ceegraph Traveler Ambulatory Eeg RecorderBio-Logic Systems Corp. · 1996
- Descendant · cites it directly · 45 of its ownK962103 Bio-Logic Sleepscan Product with Built-in OximeterBio-Logic Systems Corp. · 1996
- Descendant · 2 generations on · 42 of its ownK012437 Devilbiss Sleep Recorder Model # RM60Sunrise Medical Hhg, Inc. · 2002
- Descendant · 3 generations on · 40 of its ownK040595 ALICE 5Respironics, Inc. · 2004 · Recalled
- Descendant · 4 generations on · 18 of its ownK112102 Michele Sleep Scoring SystemsYounes Sleep Technologies · 2011
- Descendant · 5 generations on · 16 of its ownK120450 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2012
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 47 · See all- K962103Bio-Logic Sleepscan Product with Built-in OximeterBio-Logic Systems Corp. · 1996 · cites it directly45descendants
- K012437Devilbiss Sleep Recorder Model # RM60Sunrise Medical Hhg, Inc. · 2002 · 2 generations on42descendants
- K040595ALICE 5Respironics, Inc. · 2004 · 3 generations on40descendants
- K112102Michele Sleep Scoring SystemsYounes Sleep Technologies · 2011 · 4 generations on18descendants
- K120450Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2012 · 5 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954954 | Ceegraph Traveler Ambulatory Eeg Recorder | Bio-Logic Systems Corp. | 1996 | — |
| +1 | K962103 | Bio-Logic Sleepscan Product with Built-in Oximeter | Bio-Logic Systems Corp. | 1996 | — |
| +2 | K012437 | Devilbiss Sleep Recorder Model # RM60 | Sunrise Medical Hhg, Inc. | 2002 | — |
| +3 | K040595 | ALICE 5 | Respironics, Inc. | 2004 | 1 |
| +4 | K112102 | Michele Sleep Scoring Systems | Younes Sleep Technologies | 2011 | — |
| +5 | K120450 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 0 |
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.
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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (47)
See all 473 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?
- Of its descendants, K962103 (Bio-Logic Systems Corp., 1996) has gone furthest, with 45 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 | — |
https://510kreport.com/device/K954954 · printed Nov 5, 2026
Cite this page
510(k) Report. “K954954: Ceegraph Traveler Ambulatory Eeg Recorder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K954954
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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