510(k) · Cleared
ClearedRetiscan, Retiport
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roland Consult · GWE Stimulator, Photic, Evoked Response
Cleared on Mar 26, 2004 as substantially equivalent to K863956 (Doran Instruments, Inc., 1986) and 1 other predicate after a 522-day review. Its family tree reaches back 1 generation to 1986. 6 later devices descend from it.
- Decided
- Mar 26, 2004
- Review
- 522 days
- Class
- Class II
- Product code
- GWE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K863956 (1986). 2 ancestors in all. 6 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK863956 Maculoscope (TM)Doran Instruments, Inc. · 1986
- This deviceK023525 Retiscan, RetiportRoland Consult · 2004
- Descendant · cites it directly · 1 of its ownK211643 Vision Monitor - MonpackONEMetrovision · 2021
- Descendant · cites it directly · 1 of its ownK081591 NeucodiaVerisci Corporation · 2009
- Descendant · 2 generations on · 0 of its ownK221471 E3 and ProfileDiagnosys, LLC · 2022
- Descendant · cites it directly · 0 of its ownK212936 Vision Monitor- MonCvONEMetrovision · 2022
- Descendant · cites it directly · 0 of its ownK120104 Visionsearch 1Visionsearch Pty, Ltd. · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K211643Vision Monitor - MonpackONEMetrovision · 2021 · cites it directly1descendant
- K081591NeucodiaVerisci Corporation · 2009 · cites it directly1descendant
- K221471E3 and ProfileDiagnosys, LLC · 2022 · 2 generations on0descendants
- K212936Vision Monitor- MonCvONEMetrovision · 2022 · cites it directly0descendants
- K120104Visionsearch 1Visionsearch Pty, Ltd. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K863956 | Maculoscope (TM) | Doran Instruments, Inc. | 1986 | — |
| 0 (this device) | K023525 | Retiscan, Retiport | Roland Consult | 2004 | — |
| +1 | K211643 | Vision Monitor - MonpackONE | Metrovision | 2021 | — |
| +1 | K081591 | Neucodia | Verisci Corporation | 2009 | — |
| +2 | K221471 | E3 and Profile | Diagnosys, LLC | 2022 | — |
| +1 | K212936 | Vision Monitor- MonCvONE | Metrovision | 2022 | — |
| +1 | K120104 | Visionsearch 1 | Visionsearch Pty, Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 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 |
|---|---|---|---|
| * | K863956 | Maculoscope (TM)Summary page 1…Dipl. Ing. Matthias Mai Legally Marketed Predicate Device The RETI-Port/RETIscan-System is substiancially equivalent to Doran Maculoscope and the Espion System (K863956) manufactured by DORAN INSTRUMENTS, INC., and the VERIS System (KO03442) manufactured by Electro-Diagnostic Imaging, Inc. Thes… | 1986 |
| * | K003442 | Modification to Edi Veris System | 2001 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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 | — |
What is it indicated for?
Electrophysiological Test Unit for quantifying the retinal response, measuring a parameter (VEP) related to retinal response
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023525 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023525: Retiscan, Retiport.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023525
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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