# K932571: Tomey PE-400 Portable Erg & Vep with Optional PS-4

- Pathway: 510(k) (Traditional)
- Applicant: Tomey Corporation USA
- Decided: Aug 31, 1995 after 826 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
No predicates in its family tree.
4 later devices descend 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K983983: Edi Veris System (1999), 3 descendants of its own
- K043491: Enfanttm (2005), 1 descendant of its own
- K101763: Diopsys Nova Vep Vision Testing System (2011), 0 descendants of its own
- K022304: Accumap Automatic Perimeter (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K932571
Methodology: https://510kreport.com/methodology