510(k) · Cleared
ClearedNeucodia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Verisci Corporation · GWE Stimulator, Photic, Evoked Response
Cleared on May 15, 2009 as substantially equivalent to K023525 (Roland Consult, 2004) and 1 other predicate after a 343-day review. Its family tree reaches back 2 generations to 1986. 1 later device descends from it.
- Decided
- May 15, 2009
- Review
- 343 days
- Class
- Class II
- Product code
- GWE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K863956 (1986). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK863956 Maculoscope (TM)Doran Instruments, Inc. · 1986
- 1 generation backK023525 Retiscan, RetiportRoland Consult · 2004
- This deviceK081591 NeucodiaVerisci Corporation · 2009
- Descendant · cites it directly · 0 of its ownK101763 Diopsys Nova Vep Vision Testing SystemDiopsys, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K101763Diopsys Nova Vep Vision Testing SystemDiopsys, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K863956 | Maculoscope (TM) | Doran Instruments, Inc. | 1986 | — |
| −1 | K023525 | Retiscan, Retiport | Roland Consult | 2004 | — |
| 0 (this device) | K081591 | Neucodia | Verisci Corporation | 2009 | — |
| +1 | K101763 | Diopsys Nova Vep Vision Testing System | Diopsys, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K023525 | Retiscan, RetiportSummary page 1…Class: 11 2.1 Identification of Legally Marketed Predicate Devices The Neucodia system is substantially equivalent to Roland Consult's RETI-Port-Scan (K023525) and LACE Elettronica's GLAID Ocular Electrophysiology Device (K043367). The Neucodia device features are substantially equivalen… | 2004 |
| * | K043367 | Glaid Ocular Electrophysiology DeviceSummary page 1…dicate Devices The Neucodia system is substantially equivalent to Roland Consult's RETI-Port-Scan (K023525) and LACE Elettronica's GLAID Ocular Electrophysiology Device (K043367). The Neucodia device features are substantially equivalent to the predicate devices with respect to the device's general design… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101763 | Diopsys Nova Vep Vision Testing System | 2011 | 0 |
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 23 years and passes through 3 companies; a new generation was cleared every 17.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K101763 (Diopsys, Inc., 2011) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K023525.
How does its category compare?
All GWE devicesGWE Stimulator, Photic, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Neucodia system is an electrophysiological device that generates photic stimuli, and
records, processes and analyzes the resultant visual evoked potential (VEP) signals for the
study of central visual functions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081591 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081591: Neucodia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081591
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