# K233516: Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)

- Pathway: 510(k) (Traditional)
- Applicant: Reichert, Inc.
- Decided: May 1, 2024 after 182 days
- Product code: HKY (Tonometer, Manual)
- 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: 4 generations back to K943939 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153694: Icare ic100, Icare Finland OY (2016) Summary page 5.

## Indications for use
The Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes is intended to be used for the measurement of intraocular pressure of the human eye.

Source page: https://510kreport.com/device/K233516
Methodology: https://510kreport.com/methodology