510(k) · Cleared
ClearedEpochxp Neurological Workstation,Epochxp Lite Neurological Workstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axon Systems, Inc. · GWF Stimulator, Electrical, Evoked Response
Cleared on Dec 16, 2003 as substantially equivalent to K022785 (Axon Systems, Inc., 2002) and 1 other predicate after a 103-day review. Its family tree reaches back 3 generations to 1984. 1 of the 470 devices in its family, counting itself, has a Class I recall. 462 later devices descend from it.
- Decided
- Dec 16, 2003
- Review
- 103 days
- Class
- Class II
- Product code
- GWF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K842956 (1984). 7 ancestors in all. 462 later devices descend from it, 2 citing it directly. 1 of the 470 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK842956 Nicolet VikingNicolet Biomedical Instruments · 1984
- 2 generations backK971819 Epoch 2000 Neurological WorkstationAxon Systems, Inc. · 1997
- 1 generation backK022785 Epoch XP Neurological Workstation; Epoch XP Lite Neurological…Axon Systems, Inc. · 2002
- This deviceK032741 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
- Descendant · 4 generations on · 404 of its ownK124004 Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy…Medtronic Navigation, Inc. · 2013 · Recalled
Showing 5 of 462 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 462 · See all- 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
- K124004Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy TapsMedtronic Navigation, Inc. · 2013 · 4 generations on404descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K842956 | Nicolet Viking | Nicolet Biomedical Instruments | 1984 | — |
| −2 | K971819 | Epoch 2000 Neurological Workstation | Axon Systems, Inc. | 1997 | — |
| −1 | K022785 | Epoch XP Neurological Workstation; Epoch XP Lite Neurological Workstation | Axon Systems, Inc. | 2002 | — |
| 0 (this device) | 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 |
| +4 | K124004 | Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps | Medtronic Navigation, Inc. | 2013 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 8 | 0 |
| 2016 | 9 | 0 |
| 2017 | 17 | 0 |
| 2018 | 20 | 0 |
| 2019 | 31 | 0 |
| 2020 | 22 | 0 |
| 2021 | 42 | 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 summary (predicates and 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? (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 |
|---|---|---|---|
| * | K022785 | Epoch XP Neurological Workstation; Epoch XP Lite Neurological WorkstationSummary page 1…Monitor Stimulator, Electrical, Evoked Response Stimulator, Photic, Evoked Response Stimulator, Sonic, Evoked Response Procodes: GWQ, (4WE, GWF, OLTZ, GWJ, - EpochXP (K022785) Digitimer D185 (K020400) 11-] o K o3 794 Appendix I AXON s1065 oy SYSTEMS 400-2200 Oser Ave, Hauppauge, NY… | 2002 |
| * | K020400 | Digitimer D185 Multipulse Cortical StimulatorSummary page 1…rical, Evoked Response Stimulator, Photic, Evoked Response Stimulator, Sonic, Evoked Response Procodes: GWQ, (4WE, GWF, OLTZ, GWJ, - EpochXP (K022785) Digitimer D185 (K020400) 11-] o K o3 794 Appendix I AXON s1065 oy SYSTEMS 400-2200 Oser Ave, Hauppauge, NY 11788 Phone: 631.436.5112… | 2002 |
What descends from it? (462)
See all 4622 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K050798 (Axon Systems, Inc., 2005) has gone furthest, with 460 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 EpochXP Neurological Monitor is intended for use in the operating room and critical care areas for neurological monitoring and assessment. The instrument uses EEG, evoked potentials and EMG techniques to provide health care professionals with information to help assess a patient's neurological status and guide treatment during surgery or long term monitoring in the ICU
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/K032741 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032741: Epochxp Neurological Workstation,Epochxp Lite Neurological Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032741
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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