# K190382: Intraocular Pressure Tonometer EASYTON

- Pathway: 510(k) (Traditional)
- Applicant: Company Elamed
- Decided: Dec 6, 2019 after 290 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
Longest line of descent: 3 generations back to K943939 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060780: Tonometer Diaton, Ryazan State Instruments (2006) Summary page 4.

## Indications for use
The Tonometer Easyton is indicated for the measurement of intraocular pressure in human eyes.

Source page: https://510kreport.com/device/K190382
Methodology: https://510kreport.com/methodology