# K191945: KOWA nonmyd 8

- Pathway: 510(k) (Traditional)
- Applicant: Kowa Company, Ltd.
- Decided: Sep 10, 2019 after 50 days
- Product code: HKI (Camera, Ophthalmic, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K941234 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101628: Kowa Nonmyd WX, Kowa Co., Ltd. (2011) Summary page 5.

## Indications for use
KOWA nonmyd 8 is indicated for true color, infrared and fundus autofluorescent (FAF) imaging of a human retina without the use of a mydriatic agent.

Source page: https://510kreport.com/device/K191945
Methodology: https://510kreport.com/methodology