510(k) · Cleared
ClearedMedilog 9000 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oxford Medilog, Inc. · GWQ Full-Montage Standard Electroencephalograph
Cleared on Mar 24, 1983 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 88 later devices descend from it.
- Decided
- Mar 24, 1983
- Review
- 56 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 0
88 later devices descend from it, 2 citing it directly.
- This deviceK830295 Medilog 9000 SystemOxford Medilog, Inc. · 1983
- Descendant · cites it directly · 61 of its ownK971813 EMBLAFerguson Medical · 1998
- Descendant · cites it directly · 25 of its ownK170363 Ceribell Pocket EEG DeviceCeribell, Inc. · 2017
- Descendant · 2 generations on · 25 of its ownK080427 Watch-Pat Model 100S-2Itamar Medical · 2008
- Descendant · 3 generations on · 24 of its ownK081982 Watch-Pat 200S-2 (WP200S-2)Itamar Medical · 2008
- Descendant · 2 generations on · 23 of its ownK102567 Watch-Pat 200S-3 (WP200S-3)Itamar Medical, Ltd. · 2011
Showing 5 of 88 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 88 · See all- K971813EMBLAFerguson Medical · 1998 · cites it directly61descendants
- K170363Ceribell Pocket EEG DeviceCeribell, Inc. · 2017 · cites it directly25descendants
- K080427Watch-Pat Model 100S-2Itamar Medical · 2008 · 2 generations on25descendants
- K081982Watch-Pat 200S-2 (WP200S-2)Itamar Medical · 2008 · 3 generations on24descendants
- K102567Watch-Pat 200S-3 (WP200S-3)Itamar Medical, Ltd. · 2011 · 2 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K830295 | Medilog 9000 System | Oxford Medilog, Inc. | 1983 | — |
| +1 | K971813 | EMBLA | Ferguson Medical | 1998 | — |
| +1 | K170363 | Ceribell Pocket EEG Device | Ceribell, Inc. | 2017 | — |
| +2 | K080427 | Watch-Pat Model 100S-2 | Itamar Medical | 2008 | — |
| +3 | K081982 | Watch-Pat 200S-2 (WP200S-2) | Itamar Medical | 2008 | — |
| +2 | K102567 | Watch-Pat 200S-3 (WP200S-3) | Itamar Medical, Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 7 | 0 |
| 2023 | 9 | 0 |
| 2024 | 9 | 0 |
| 2025 | 15 | 0 |
| 2026 | 11 | 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? (88)
See all 882 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, K971813 (Ferguson Medical, 1998) has gone furthest, with 61 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/K830295 · printed Nov 3, 2026
Cite this page
510(k) Report. “K830295: Medilog 9000 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K830295
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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