# K880920: Laser Flare Cell Meter FC-1000

- Pathway: 510(k) (Traditional)
- Applicant: Kowa Optimed, Inc.
- Decided: Sep 27, 1988 after 207 days
- Product code: HJO (Biomicroscope, Slit-Lamp, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K091039: Kowa, FM-600, Model LSS50 (2009), 1 descendant of its own
- K261255: Kowa FM-600 (2026), 0 descendants of its own

Source page: https://510kreport.com/device/K880920
Methodology: https://510kreport.com/methodology