510(k) · Cleared
ClearedTomey PE-400 Portable Erg & Vep with Optional PS-4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tomey Corporation USA · GWE Stimulator, Photic, Evoked Response
Cleared on Aug 31, 1995 after an 826-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Aug 31, 1995
- Review
- 826 days
- Class
- Class II
- Product code
- GWE
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK932571 Tomey PE-400 Portable Erg & Vep with Optional PS-4Tomey Corporation USA · 1995
- Descendant · cites it directly · 3 of its ownK983983 Edi Veris SystemElectro-Diagnostic Imaging, Inc. · 1999
- Descendant · 2 generations on · 1 of its ownK043491 EnfanttmDiopsys, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 0 of its ownK101763 Diopsys Nova Vep Vision Testing SystemDiopsys, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK022304 Accumap Automatic PerimeterObjectivision Pty, Ltd. · 2003
Most influential descendants
Showing 4 of 4 · See all- K983983Edi Veris SystemElectro-Diagnostic Imaging, Inc. · 1999 · cites it directly3descendants
- K043491EnfanttmDiopsys, Inc. · 2005 · 2 generations on1descendant
- K101763Diopsys Nova Vep Vision Testing SystemDiopsys, Inc. · 2011 · 3 generations on0descendants
- K022304Accumap Automatic PerimeterObjectivision Pty, Ltd. · 2003 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K932571 | Tomey PE-400 Portable Erg & Vep with Optional PS-4 | Tomey Corporation USA | 1995 | — |
| +1 | K983983 | Edi Veris System | Electro-Diagnostic Imaging, Inc. | 1999 | — |
| +2 | K043491 | Enfanttm | Diopsys, Inc. | 2005 | 1 |
| +3 | K101763 | Diopsys Nova Vep Vision Testing System | Diopsys, Inc. | 2011 | — |
| +2 | K022304 | Accumap Automatic Perimeter | Objectivision Pty, Ltd. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2011 | 1 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K983983 | Edi Veris System | 1999 | 3 |
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, K983983 (Electro-Diagnostic Imaging, Inc., 1999) has gone furthest, with 3 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/K932571 · printed Nov 5, 2026
Cite this page
510(k) Report. “K932571: Tomey PE-400 Portable Erg & Vep with Optional PS-4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K932571
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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