510(k) · Cleared
ClearedVision Monitor - MonpackONE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Metrovision · GWE Stimulator, Photic, Evoked Response
Cleared on Jul 26, 2021 as substantially equivalent to K023525 (Roland Consult, 2004) after a 60-day review. Its family tree reaches back 2 generations to 1986. 1 later device descends from it.
- Decided
- Jul 26, 2021
- Review
- 60 days
- Class
- Class II
- Product code
- GWE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K863956 (1986). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K221471E3 and ProfileDiagnosys, LLC · 2022 · 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) | K211643 | Vision Monitor - MonpackONE | Metrovision | 2021 | — |
| +1 | K221471 | E3 and Profile | Diagnosys, LLC | 2022 | — |
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 |
|---|---|---|
| 2022 | 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 K221471 E3 and Profilescore 5.0 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 4…egally Marketed Predicate Device The Vision Monitor MonPackONE system is substantially equivalent to RETI-Port/SCAN systems manufactured by ROLAND CONSULT 510(k) number K023525. They are all hardware and software products. The Vision Monitor MonPackONE system is substantially equivalent to the predicate d… | 2004 |
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 |
|---|---|---|---|
| K221471 | E3 and Profile | 2022 | 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 35 years and passes through 3 companies; a new generation was cleared every 17.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K221471 (Diagnosys, LLC, 2022) 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. 2021, 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 Vision Monitor MonPackONE system is an electrodiagnostic device used to generate photic signals and to measure and display the electrical signals generated by the retina and the visual nervous system. It displays digitized electroretinogram (ERG), visual evoked potential (VEP) and sensory electro-oculogram (EOG) signals, power spectra and topographic maps. These functions are controlled and interpreted by trained medical professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211643 · printed Nov 3, 2026
Cite this page
510(k) Report. “K211643: Vision Monitor - MonpackONE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K211643
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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