510(k) · Cleared
ClearedDigitimer D185 Multipulse Cortical Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meps, LLC · GWF Stimulator, Electrical, Evoked Response
Cleared on Aug 23, 2002 after a 198-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 469 devices in its family, counting itself, has a Class I recall. 468 later devices descend from it.
- Decided
- Aug 23, 2002
- Review
- 198 days
- Class
- Class II
- Product code
- GWF
- Recalls
- None
- Predicates
- 0
468 later devices descend from it, 5 citing it directly. 1 of the 469 devices in this family, counting this one, has a Class I recall.
- This deviceK020400 Digitimer D185 Multipulse Cortical StimulatorMeps, LLC · 2002
- Descendant · cites it directly · 462 of its ownK032741 Epochxp Neurological Workstation,Epochxp Lite Neurological WorkstationAxon Systems, Inc. · 2003
- Descendant · cites it directly · 460 of its ownK050798 Eclipse Neurological WorkstationAxon Systems, Inc. · 2005
- Descendant · 2 generations on · 450 of its ownK061113 OrthomonAxon Systems, Inc. · 2006
- Descendant · 2 generations on · 426 of its ownK061639 Eclipse TCD Neurovascular Workstation; Elclipse Neurological…Axon Systems, Inc. · 2006
- Descendant · 3 generations on · 418 of its ownK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
Showing 5 of 468 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub8 generations on · 2021
Most influential descendants
Showing 5 of 468 · See all- K032741Epochxp Neurological Workstation,Epochxp Lite Neurological WorkstationAxon Systems, Inc. · 2003 · cites it directly462descendants
- K050798Eclipse Neurological WorkstationAxon Systems, Inc. · 2005 · cites it directly460descendants
- K061113OrthomonAxon Systems, Inc. · 2006 · 2 generations on450descendants
- K061639Eclipse TCD Neurovascular Workstation; Elclipse Neurological Workstation with TCD and…Axon Systems, Inc. · 2006 · 2 generations on426descendants
- K111520Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · 3 generations on418descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020400 | Digitimer D185 Multipulse Cortical Stimulator | Meps, LLC | 2002 | — |
| +1 | K032741 | Epochxp Neurological Workstation,Epochxp Lite Neurological Workstation | Axon Systems, Inc. | 2003 | — |
| +1 | K050798 | Eclipse Neurological Workstation | Axon Systems, Inc. | 2005 | — |
| +2 | K061113 | Orthomon | Axon Systems, Inc. | 2006 | — |
| +2 | K061639 | Eclipse TCD Neurovascular Workstation; Elclipse Neurological Workstation with… | Axon Systems, Inc. | 2006 | — |
| +3 | K111520 | Ipc Powerease System | Medtronic Xomed, Inc. | 2011 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 8 | 0 |
| 2016 | 9 | 0 |
| 2017 | 18 | 0 |
| 2018 | 20 | 0 |
| 2019 | 31 | 0 |
| 2020 | 22 | 0 |
| 2021 | 43 | 1 |
| 2022 | 48 | 0 |
| 2023 | 64 | 0 |
| 2024 | 62 | 0 |
| 2025 | 64 | 0 |
| 2026 | 57 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (468)
See all 4685 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032741 | Epochxp Neurological Workstation,Epochxp Lite Neurological Workstation | 2003 | 462 |
| K050798 | Eclipse Neurological Workstation | 2005 | 460 |
| K051357 | DS7A Constant Current High Voltage Stimulator, Model DS7A; DS7AH Constant Current High… | 2005 | 40 |
| K071969 | Sen-4100 Electric Stimulator | 2008 | 14 |
| K110410 | MS-120BK Electric Stimulator (Extension Unit) | 2011 | 13 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K032741 (Axon Systems, Inc., 2003) has gone furthest, with 462 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 | — |
What is it indicated for?
The Digitimer D185 is used for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K020400 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020400: Digitimer D185 Multipulse Cortical Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020400
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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