# K253039: Auto Kerato-Refracto Tonometer TRK-3 Omnia

- Pathway: 510(k) (Traditional)
- Applicant: Topcon Corporation
- Decided: Nov 7, 2025 after 46 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: 5 generations back to K920906 (1992). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180820: Tono Vue Non-Contact Tonometer, Crystalvue Medical Corporation (2018) Summary page 6.
- K142417: SP-1PSpecular Microscope, Topcon Corporation (2015) Summary page 6.

## Indications for use
TRK-3 OMNIA is a combination of the non-contact tonometer and pachymeter. The device is indicated for automatic measurement of intraocular pressure without contacting the eye (with less than 3 diopters of corneal astigmatism); and measurement of central corneal thickness.

Source page: https://510kreport.com/device/K253039
Methodology: https://510kreport.com/methodology