510(k) · Cleared
Recalled · Class II · 2013Dantec Keypoint
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mckenna & Cuneo · GWF Stimulator, Electrical, Evoked Response
Cleared on Sep 19, 1995 after a 369-day review. The FDA summary names no predicate by number. 21 later devices descend from it. It has been recalled once.
- Decided
- Sep 19, 1995
- Review
- 369 days
- Class
- Class II
- Product code
- GWF
- Recalls
- 1
- Predicates
- 0
21 later devices descend from it, 4 citing it directly.
- This deviceK944547 Dantec KeypointMckenna & Cuneo · 1995
- Descendant · cites it directly · 15 of its ownK070109 Neurometrix AdvanceNeurometrix, Inc. · 2008
- Descendant · 2 generations on · 12 of its ownK120979 Carefusion Nicolet EdxCarefusion 209, Inc. · 2012
- Descendant · 3 generations on · 7 of its ownK162199 Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc. · 2017 · Recalled
- Descendant · 4 generations on · 5 of its ownK212166 ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert…Inomed Medizintechnik GmbH · 2022
- Descendant · 3 generations on · 3 of its ownK130346 Synergy Focus Desktop Version; Synergy Focus Laptop VersionNatus Neurology Incorporated · 2013
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K070109Neurometrix AdvanceNeurometrix, Inc. · 2008 · cites it directly15descendants
- K120979Carefusion Nicolet EdxCarefusion 209, Inc. · 2012 · 2 generations on12descendants
- K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc. · 2017 · 3 generations on7descendants
- K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH · 2022 · 4 generations on5descendants
- K130346Synergy Focus Desktop Version; Synergy Focus Laptop VersionNatus Neurology Incorporated · 2013 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944547 | Dantec Keypoint | Mckenna & Cuneo | 1995 | — |
| +1 | K070109 | Neurometrix Advance | Neurometrix, Inc. | 2008 | — |
| +2 | K120979 | Carefusion Nicolet Edx | Carefusion 209, Inc. | 2012 | — |
| +3 | K162199 | Cascade IOMAX Intraoperative Monitor | Cadwell Industries, Inc. | 2017 | 3 |
| +4 | K212166 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | Inomed Medizintechnik GmbH | 2022 | — |
| +3 | K130346 | Synergy Focus Desktop Version; Synergy Focus Laptop Version | Natus Neurology Incorporated | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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?
The FDA summary names no predicate by number.
What descends from it? (21)
See all 214 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 9, 2013 | Class II | Z-1407-2013 | Software design | Alpine Biomed ApS is recalling Natus neurology Dantec KEYPOINT.NET ver. 2.20 Software due to the presence of a software bug. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K070109 (Neurometrix, Inc., 2008) has gone furthest, with 15 descendants of its own.
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 | — |
https://510kreport.com/device/K944547 · printed Nov 6, 2026
Cite this page
510(k) Report. “K944547: Dantec Keypoint.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K944547
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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