510(k) · Cleared
ClearedOkti
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Compumedics Limited · GWQ Full-Montage Standard Electroencephalograph
Cleared on Feb 9, 2023 as substantially equivalent to K093223 (Compumedics Limited, 2010) after a 30-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Feb 9, 2023
- Review
- 30 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K000068 (2000). 15 ancestors in all, the oldest K873535 (1987). No later device cites it as a predicate yet.
- Root · 4 generations backK000068 Compumedics E-Series Eeg SystemCompumedics Neuro Science Pty, Ltd. · 2000 · Recalled
- 3 generations backK021176 Compumedics Somte SystemCompumedics Limited · 2003
- 2 generations backK040194 Compumedics Summit IPCompumedics USA, Ltd. · 2004
- 1 generation backK093223 Compumedics Grael System, Models: Grael, Grael EcgCompumedics Limited · 2010
- This deviceK230073 OktiCompumedics Limited · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000068 | Compumedics E-Series Eeg System | Compumedics Neuro Science Pty, Ltd. | 2000 | 1 |
| −3 | K021176 | Compumedics Somte System | Compumedics Limited | 2003 | — |
| −2 | K040194 | Compumedics Summit IP | Compumedics USA, Ltd. | 2004 | — |
| −1 | K093223 | Compumedics Grael System, Models: Grael, Grael Ecg | Compumedics Limited | 2010 | — |
| 0 (this device) | K230073 | Okti | Compumedics Limited | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 2 | 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 |
|---|---|---|---|
| * | K093223 | Compumedics Grael System, Models: Grael, Grael EcgSummary page 4…Predicate Device Information Trade Name: Grael System Model: Grael EEG Manufacturer: Compumedics Limited 510(k) number: K093223 510(k) Decision Date: 15th January 2010 Classification: Full-Montage Standard Electroencephalograph, Ventilatory Effort… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- 1 of the 15 ancestors has a recall of any class.
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
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 Okti System is intended for use in the recording, displaying, analysis, printing and storage of human biological parameters such as heart and muscle activity, eye movement, breathing and body movements to assist in the diagnosis of various neurological disorders. The Okti is designed for use in a hospital or other clinical environment. The Okti is only to be used under the direction of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230073 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230073: Okti.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230073
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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