510(k) · Cleared
ClearedDiopsys Nova Vep Vision Testing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diopsys, Inc. · GWE Stimulator, Photic, Evoked Response
Cleared on May 9, 2011 as substantially equivalent to K043491 (Diopsys, Inc., 2005) and 1 other predicate after a 320-day review. Its family tree reaches back 3 generations to 1976.
- Decided
- May 9, 2011
- Review
- 320 days
- Class
- Class II
- Product code
- GWE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K760199 (1976). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK760199 ElectroretinographLkc Technologies, Inc. · 1976
- 2 generations backK983983 Edi Veris SystemElectro-Diagnostic Imaging, Inc. · 1999
- 1 generation backK043491 EnfanttmDiopsys, Inc. · 2005 · Recalled
- This deviceK101763 Diopsys Nova Vep Vision Testing SystemDiopsys, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K760199 | Electroretinograph | Lkc Technologies, Inc. | 1976 | — |
| −2 | K983983 | Edi Veris System | Electro-Diagnostic Imaging, Inc. | 1999 | — |
| −1 | K043491 | Enfanttm | Diopsys, Inc. | 2005 | 1 |
| 0 (this device) | K101763 | Diopsys Nova Vep Vision Testing System | Diopsys, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 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 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? (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 |
|---|---|---|---|
| * | K043491 | EnfanttmSummary page 1…ly Marketed Predicate Devices The Diopsys NOVA VEP Vision Testing System (NOVA), is substantially.cquivalent to the Diopsys Enfant® Pediatric VEP Vision Testing System (K043491) and the VeriSci Corporation Neucodia System (K081591). The NOVA device is substantially equivalent to the predicate devices with… | 2005 |
| * | K081591 | NeucodiaSummary page 1…sion Testing System (NOVA), is substantially.cquivalent to the Diopsys Enfant® Pediatric VEP Vision Testing System (K043491) and the VeriSci Corporation Neucodia System (K081591). The NOVA device is substantially equivalent to the predicate devices with regard to device features, designs, operational proce… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 35 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- 1 of the 9 ancestors has a recall of any class.
How does its category compare?
All GWE devicesGWE Stimulator, Photic, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The NOVA is an electrophysiological device that generates photic stimuli, and records, processes, and analyzes the resultant visual evoked potential (VEP) signals to provide information about the visual system structural and neural abnormalities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101763 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101763: Diopsys Nova Vep Vision Testing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101763
Report an extraction error
Are you the manufacturer?
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