# K053444: Kowa KT-800

- Pathway: 510(k) (Traditional)
- Applicant: Kowa Co., Ltd.
- Decided: Jun 9, 2006 after 182 days
- Product code: HKX (Tonometer, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Kowa Automated Tonometer KT-500: named in the summary without a submission number

## Indications for use
The KOWA KT-800 is indicated for measuring intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma.

Source page: https://510kreport.com/device/K053444
Methodology: https://510kreport.com/methodology