510(k) · Cleared
ClearedGalileo Evoked Potentialre
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosound, Inc. · GWF Stimulator, Electrical, Evoked Response
Cleared on Feb 26, 1997 as substantially equivalent to K922488 (Biosound, Inc., 1993) and 1 other predicate after a 166-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Feb 26, 1997
- Review
- 166 days
- Class
- Class II
- Product code
- GWF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K890495 (1989). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK890495 Nicolet Viking II SystemNicolet Instrument Corp. · 1989
- This deviceK963662 Galileo Evoked PotentialreBiosound, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K890495 | Nicolet Viking II System | Nicolet Instrument Corp. | 1989 | — |
| 0 (this device) | K963662 | Galileo Evoked Potentialre | Biosound, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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 GWF? 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 GWF device
- #1 K263010 ISIS Headboxes, ISIS Neurostimulator, ISIS…score 17.5 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K922488 | Phasis ElectromyographSummary page 2…Potential Electroencephalograph Classification Name(s): Electroencephalograph Classification Number: 84 GWQ 807.92(a)(3) Predicate Device(s) ¢ Phasis Electromyograph K922488 ¢ Nicolet Viking II System K890495 Additional Substantial Equivalence information is provided in the following substantial Equi… | 1993 |
| * | K890495 | Nicolet Viking II SystemSummary page 2…assification Name(s): Electroencephalograph Classification Number: 84 GWQ 807.92(a)(3) Predicate Device(s) ¢ Phasis Electromyograph K922488 ¢ Nicolet Viking II System K890495 Additional Substantial Equivalence information is provided in the following substantial Equivalence Comparision Table. 807.92(a… | 1989 |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K922488.
How does its category compare?
All GWF devicesGWF Stimulator, Electrical, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GWF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWF
92in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWF
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWF
1,034in 2025
MAUDE reports naming product code GWF, 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 | 3 | 69 | 0 | 2 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 5 | 178 | 0 | 1 |
| 2010 | 3 | 269 | 0 | 4 |
| 2011 | 2 | — | 0 | 10 |
| 2012 | 4 | 230 | 1 | 44 |
| 2013 | 3 | 174 | 0 | 89 |
| 2014 | 1 | — | 0 | 25 |
| 2015 | 2 | — | 1 | 22 |
| 2016 | 1 | — | 0 | 20 |
| 2017 | 3 | 169 | 0 | 60 |
| 2018 | 0 | — | 0 | 58 |
| 2019 | 1 | — | 0 | 94 |
| 2020 | 1 | — | 0 | 65 |
| 2021 | 2 | — | 0 | 55 |
| 2022 | 2 | — | 0 | 45 |
| 2023 | 2 | — | 0 | 150 |
| 2024 | 4 | 92 | 0 | 854 |
| 2025 | 1 | — | 0 | 1,034 |
| 2026 | 3 | 125 | 2 | — |
What is it indicated for?
The Galileo Electroencephalograph with Evoked Potential option is indicated for use in the detection and display of evoked responses of electrical activity of the brain and the peripheral nervous system.
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/K963662 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963662: Galileo Evoked Potentialre.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963662
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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