510(k) · Cleared
ClearedMaculoscope (TM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Doran Instruments, Inc. · GWE Stimulator, Photic, Evoked Response
Cleared on Nov 13, 1986 after a 34-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- Nov 13, 1986
- Review
- 34 days
- Class
- Class II
- Product code
- GWE
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 3 citing it directly.
- This deviceK863956 Maculoscope (TM)Doran Instruments, Inc. · 1986
- Descendant · cites it directly · 6 of its ownK023525 Retiscan, RetiportRoland Consult · 2004
- Descendant · cites it directly · 3 of its ownK983983 Edi Veris SystemElectro-Diagnostic Imaging, Inc. · 1999
- Descendant · 2 generations on · 1 of its ownK211643 Vision Monitor - MonpackONEMetrovision · 2021
- Descendant · 2 generations on · 1 of its ownK081591 NeucodiaVerisci Corporation · 2009
- Descendant · cites it directly · 1 of its ownK043491 EnfanttmDiopsys, Inc. · 2005 · Recalled
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K023525Retiscan, RetiportRoland Consult · 2004 · cites it directly6descendants
- K983983Edi Veris SystemElectro-Diagnostic Imaging, Inc. · 1999 · cites it directly3descendants
- K211643Vision Monitor - MonpackONEMetrovision · 2021 · 2 generations on1descendant
- K081591NeucodiaVerisci Corporation · 2009 · 2 generations on1descendant
- K043491EnfanttmDiopsys, Inc. · 2005 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K863956 | Maculoscope (TM) | Doran Instruments, Inc. | 1986 | — |
| +1 | K023525 | Retiscan, Retiport | Roland Consult | 2004 | — |
| +1 | K983983 | Edi Veris System | Electro-Diagnostic Imaging, Inc. | 1999 | — |
| +2 | K211643 | Vision Monitor - MonpackONE | Metrovision | 2021 | — |
| +2 | K081591 | Neucodia | Verisci Corporation | 2009 | — |
| +1 | K043491 | Enfanttm | Diopsys, Inc. | 2005 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (10)
3 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?
- Of its descendants, K023525 (Roland Consult, 2004) has gone furthest, with 6 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/K863956 · printed Nov 6, 2026
Cite this page
510(k) Report. “K863956: Maculoscope (TM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K863956
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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