# K043491: Enfanttm

- Pathway: 510(k) (Traditional)
- Applicant: Diopsys, Inc.
- Decided: Mar 16, 2005 after 89 days
- Product code: GWE (Stimulator, Photic, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1890
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K760199 (1976). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K863956: Maculoscope (TM), Doran Instruments, Inc. (1986) Summary page 1.
- K983983: Edi Veris System, Electro-Diagnostic Imaging, Inc. (1999) Summary page 1.
- (no number) Maculoscope: named in the summary without a submission number

## Most influential descendants
- K101763: Diopsys Nova Vep Vision Testing System (2011), 0 descendants of its own

## Recalls of this device
- Apr 2, 2007 · Not classified · Z-1437-2010: The computer based system may lose test counts when the time in the device was changed during a changeover from standard time to daylight savings time in March 2007.

## Indications for use
The Enfant is a non-invasive medical device to screen, without dilation or sedation, for visual disorders in infants and pre-school children. The system uses Visual Evoked potentials to provide information about the visual pathway function and about optical or neural abnormalities related to vision.

Source page: https://510kreport.com/device/K043491
Methodology: https://510kreport.com/methodology