# K261255: Kowa FM-600

- Pathway: 510(k) (Traditional)
- Applicant: Kowa Company, Ltd. Chofu Factory
- Decided: Sep 11, 2026 after 148 days
- Product code: MYC (Ophthalmoscope, Laser, Scanning)
- Device class: 2
- Regulation: 21 CFR 886.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K880920 (1988). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091039: Kowa, FM-600, Model LSS50, Kowa Co., Ltd. (2009) Summary page 5.

## Indications for use
KOWA FM-600 is an instrument to measure the protein level contained in aqueous humor of the anterior chamber of human eye.

Source page: https://510kreport.com/device/K261255
Methodology: https://510kreport.com/methodology