# K053026: Kowa Nonmyd 7, Kowa Nonmyd a-D

- Pathway: 510(k) (Traditional)
- Applicant: Kowa Co., Ltd.
- Decided: Nov 10, 2005 after 14 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: 3 generations back to K941234 (1995). 3 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014274: Non-Mydriatic Fundus Camera, Model NM-1000, Nidek, Inc. (2002) Summary page 3.

## Most influential descendants
- K101628: Kowa Nonmyd WX (2011), 2 descendants of its own
- K191945: KOWA nonmyd 8 (2019), 0 descendants of its own
- K132987: Cobra Fundus Camera (2014), 0 descendants of its own
- K062356: Kowa Nonmyd Alpha-D (2006), 0 descendants of its own

## Indications for use
The KOWA nonmyd series, non-mydriatic fundus camera, are intended for use with retina image capturing. The retina image can be stored to an external hard disk drive or transferred in other formats through memory card or serial interface depending on the output interface available for each device.

Source page: https://510kreport.com/device/K053026
Methodology: https://510kreport.com/methodology