# K863956: Maculoscope (TM)

- Pathway: 510(k) (Traditional)
- Applicant: Doran Instruments, Inc.
- Decided: Nov 13, 1986 after 34 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.
10 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K023525: Retiscan, Retiport (2004), 6 descendants of its own
- K983983: Edi Veris System (1999), 3 descendants of its own
- K211643: Vision Monitor - MonpackONE (2021), 1 descendant of its own
- K081591: Neucodia (2009), 1 descendant of its own
- K043491: Enfanttm (2005), 1 descendant of its own

Source page: https://510kreport.com/device/K863956
Methodology: https://510kreport.com/methodology