# K180820: Tono Vue Non-Contact Tonometer

- Pathway: 510(k) (Traditional)
- Applicant: Crystalvue Medical Corporation
- Decided: Dec 14, 2018 after 260 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: 4 generations back to K943939 (1995). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111710: Full Auto Tonometer Model TX-20, Canon Inc. -Medical Equipment Group (2011) Summary page 5.

## Most influential descendants
- K253039: Auto Kerato-Refracto Tonometer TRK-3 Omnia (2025), 0 descendants of its own
- K223739: VS Tabletop Tonometer (2023), 0 descendants of its own

## Indications for use
The TonoVue is a non-contact tonometer that intended to measure the intra-ocular pressure of the eye in patients with less than 3 diopters of corneal astigmatism.

Source page: https://510kreport.com/device/K180820
Methodology: https://510kreport.com/methodology