510(k) · Cleared
ClearedElectroencephalograph (Eeg)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Moberg Medical, Inc. · GWF Stimulator, Electrical, Evoked Response
Cleared on Mar 1, 1996 as substantially equivalent to K914571 (Moberg Medical, Inc., 1992) and 1 other predicate after a 45-day review. Its family tree reaches back 1 generation to 1985. 16 later devices descend from it.
- Decided
- Mar 1, 1996
- Review
- 45 days
- Class
- Class II
- Product code
- GWF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K851300 (1985). 2 ancestors in all. 16 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK851300 Neuropack 8, Mee-4108Nihon Kohden America, Inc. · 1985
- This deviceK960170 Electroencephalograph (Eeg)Moberg Medical, Inc. · 1996
- Descendant · cites it directly · 14 of its ownK080217 Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · Recalled
- Descendant · cites it directly · 8 of its ownK081551 Twin Neurotrac-IiiAstro-Med, Inc. · 2008
- Descendant · 2 generations on · 7 of its ownK092573 Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010
- Descendant · 3 generations on · 5 of its ownK120485 Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa…Nihon Kohden America, Inc. · 2012
- Descendant · 2 generations on · 3 of its ownK173366 NicoletOneNatus Neurology Incorporated · 2018
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K080217Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · cites it directly14descendants
- K081551Twin Neurotrac-IiiAstro-Med, Inc. · 2008 · cites it directly8descendants
- K092573Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010 · 2 generations on7descendants
- K120485Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT PNihon Kohden America, Inc. · 2012 · 3 generations on5descendants
- K173366NicoletOneNatus Neurology Incorporated · 2018 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K851300 | Neuropack 8, Mee-4108 | Nihon Kohden America, Inc. | 1985 | — |
| 0 (this device) | K960170 | Electroencephalograph (Eeg) | Moberg Medical, Inc. | 1996 | — |
| +1 | K080217 | Component Neuromonitoring System | Moberg Research, Inc. | 2008 | 1 |
| +1 | K081551 | Twin Neurotrac-Iii | Astro-Med, Inc. | 2008 | — |
| +2 | K092573 | Nihon Kohden QP-160AK Eeg Trend Program | Nihon Kohden America, Inc. | 2010 | — |
| +3 | K120485 | Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend… | Nihon Kohden America, Inc. | 2012 | — |
| +2 | K173366 | NicoletOne | Natus Neurology Incorporated | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (4)
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 |
|---|---|---|---|
| * | K914571 | Neurotrac IISummary page 2…All data can be printed for immediate hard copy interpretation. The Neurotrac II-EP Moberg Medical, Inc. (MM designs and manufactures the Neurotrac II monitor (5 10k# K914571A). The Neurotrac Il monitors brain function via the electroencephalogram (EEG). The new Neurotrac II-EP is an enhanced version of… | 1992 |
| * | K851300 | Neuropack 8, Mee-4108Summary page 1…€371 Excel Cadwell Laboratories, Inc. *x One of many Models for EP/EEG carried 909 N. Kellogg St. by Cadwell. Kennewick. WA 99336 Neuropack 8 Nihon Kohden America Inc. K851300 8-channel version of Neuropack product 2601 Campus Dr. Irvine. CA 92715 line which includes Neuropack 2, Neuropack 4 Mini **… | 1985 |
| * | — | Viking IV Named without a submission number | |
| * | — | Excel Named without a submission number |
What descends from it? (16)
See all 162 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?
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?
To record the electroencephalogram (EEG) and evoked potentials (EP’s) over extended periods of time such as during surgery and intensive care stays in order for trained health care professionals to observe changes.
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/K960170 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960170: Electroencephalograph (Eeg).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960170
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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