# K211643: Vision Monitor - MonpackONE

- Pathway: 510(k) (Traditional)
- Applicant: Metrovision
- Decided: Jul 26, 2021 after 60 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.
1 later device descends from it; 1 cites it directly.
0 of 5 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.

## Most influential descendants
- K221471: E3 and Profile (2022), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K211643
Methodology: https://510kreport.com/methodology