# K212936: Vision Monitor- MonCvONE

- Pathway: 510(k) (Traditional)
- Applicant: Metrovision
- Decided: Nov 21, 2022 after 432 days
- Product code: GWE (Stimulator, Photic, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K863956 (1986). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023525: Retiscan, Retiport, Roland Consult (2004) Summary page 4.

## Indications for use
The Vision Monitor MonCvONE system is a non-invasive medical device used to generate photic stimulations and to register the electrical responses generated by the retina and the visual nervous system in addition to psychophysical and pupillary responses. It displays digitized electroretinogram (ERG), visual evoked potential (VEP), sensory electro- oculogram (EOG), power spectra and topographic maps. These functions are controlled and interpreted by trained medical professionals.

Source page: https://510kreport.com/device/K212936
Methodology: https://510kreport.com/methodology