510(k) · Cleared
ClearedModel 8400 W/Modifications (Spectrum 32)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cadwell Laboratories, Inc. · GWE Stimulator, Photic, Evoked Response
Cleared on Nov 18, 1986 after a 259-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 30 later devices descend from it.
- Decided
- Nov 18, 1986
- Review
- 259 days
- Class
- Class II
- Product code
- GWE
- Recalls
- None
- Predicates
- 0
30 later devices descend from it, 2 citing it directly.
- This deviceK860801 Model 8400 W/Modifications (Spectrum 32)Cadwell Laboratories, Inc. · 1986
- Descendant · cites it directly · 29 of its ownK974748 Neurometric Analysis SystemNxlink, Ltd. · 1998
- Descendant · cites it directly · 21 of its ownK041263 Neuroguide Analysis SystemApplied Neuroscience, Inc. · 2004
- Descendant · 2 generations on · 9 of its ownK092039 Identevent, Version 1.0GOptima Neuroscience, Inc. · 2009
- Descendant · 3 generations on · 7 of its ownK092573 Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010
- Descendant · 2 generations on · 6 of its ownK161068 Ahead 300Brainscope Company, Inc. · 2016
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K974748Neurometric Analysis SystemNxlink, Ltd. · 1998 · cites it directly29descendants
- K041263Neuroguide Analysis SystemApplied Neuroscience, Inc. · 2004 · cites it directly21descendants
- K092039Identevent, Version 1.0GOptima Neuroscience, Inc. · 2009 · 2 generations on9descendants
- K092573Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010 · 3 generations on7descendants
- K161068Ahead 300Brainscope Company, Inc. · 2016 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K860801 | Model 8400 W/Modifications (Spectrum 32) | Cadwell Laboratories, Inc. | 1986 | — |
| +1 | K974748 | Neurometric Analysis System | Nxlink, Ltd. | 1998 | — |
| +1 | K041263 | Neuroguide Analysis System | Applied Neuroscience, Inc. | 2004 | — |
| +2 | K092039 | Identevent, Version 1.0G | Optima Neuroscience, Inc. | 2009 | — |
| +3 | K092573 | Nihon Kohden QP-160AK Eeg Trend Program | Nihon Kohden America, Inc. | 2010 | — |
| +2 | K161068 | Ahead 300 | Brainscope Company, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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 GWE? 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 GWE device
- #1 K211643 Vision Monitor - MonpackONEscore 5.0 · 2 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? (30)
See all 302 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, K974748 (Nxlink, Ltd., 1998) has gone furthest, with 29 descendants of its own.
How does its category compare?
All GWE devicesGWE Stimulator, Photic, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GWE
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · GWE
Too few GWE 510(k)s in any year since 2007 to give a median.
Recalls per year · GWE
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWE
1in 2025
MAUDE reports naming product code GWE, 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 | 0 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 1 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K860801 · printed Nov 5, 2026
Cite this page
510(k) Report. “K860801: Model 8400 W/Modifications (Spectrum 32).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K860801
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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