# K963079: Canon TX-10 Tonometer

- Pathway: 510(k) (Traditional)
- Applicant: Canon USA, Inc.
- Decided: Mar 3, 1997 after 208 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: 1 generation back to K943939 (1995). 1 ancestor in all.
6 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943939: Non-Contact Tonometer T-2, Canon, Inc. (1995) Summary page 1.

## Most influential descendants
- K023816: Canon Full Auto Tonometer TX-F (2002), 5 descendants of its own
- K111710: Full Auto Tonometer Model TX-20 (2011), 3 descendants of its own
- K180820: Tono Vue Non-Contact Tonometer (2018), 2 descendants of its own
- 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 TX-10 tonometer is intended to be used for the measurement of intraocular pressure of the human eye.

Source page: https://510kreport.com/device/K963079
Methodology: https://510kreport.com/methodology