510(k) · Cleared
ClearedCanon Full Auto Tonometer TX-F
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canon, Inc.-Utsunomiya Optical Products Operation · HKX Tonometer, Ac-Powered
Cleared on Nov 26, 2002 as substantially equivalent to K963079 (Canon USA, Inc., 1997) after an 11-day review. Its family tree reaches back 2 generations to 1995. 5 later devices descend from it.
- Decided
- Nov 26, 2002
- Review
- 11 days
- Class
- Class II
- Product code
- HKX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K943939 (1995). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK943939 Non-Contact Tonometer T-2Canon, Inc. · 1995
- 1 generation backK963079 Canon TX-10 TonometerCanon USA, Inc. · 1997
- This deviceK023816 Canon Full Auto Tonometer TX-FCanon, Inc.-Utsunomiya Optical Products Operation · 2002
- Descendant · cites it directly · 3 of its ownK111710 Full Auto Tonometer Model TX-20Canon Inc. -Medical Equipment Group · 2011
- Descendant · 2 generations on · 2 of its ownK180820 Tono Vue Non-Contact TonometerCrystalvue Medical Corporation · 2018
- Descendant · 3 generations on · 0 of its ownK253039 Auto Kerato-Refracto Tonometer TRK-3 OmniaTopcon Corporation · 2025
- Descendant · 3 generations on · 0 of its ownK223739 VS Tabletop TonometerMedimaging Integrated Solution, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK073087 Non-Contact Tonometer, Model FT-1000Tomey Corporation · 2008
Most influential descendants
Showing 5 of 5 · See all- K111710Full Auto Tonometer Model TX-20Canon Inc. -Medical Equipment Group · 2011 · cites it directly3descendants
- K180820Tono Vue Non-Contact TonometerCrystalvue Medical Corporation · 2018 · 2 generations on2descendants
- K253039Auto Kerato-Refracto Tonometer TRK-3 OmniaTopcon Corporation · 2025 · 3 generations on0descendants
- K223739VS Tabletop TonometerMedimaging Integrated Solution, Inc. · 2023 · 3 generations on0descendants
- K073087Non-Contact Tonometer, Model FT-1000Tomey Corporation · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K943939 | Non-Contact Tonometer T-2 | Canon, Inc. | 1995 | — |
| −1 | K963079 | Canon TX-10 Tonometer | Canon USA, Inc. | 1997 | — |
| 0 (this device) | K023816 | Canon Full Auto Tonometer TX-F | Canon, Inc.-Utsunomiya Optical Products Operation | 2002 | — |
| +1 | K111710 | Full Auto Tonometer Model TX-20 | Canon Inc. -Medical Equipment Group | 2011 | — |
| +2 | K180820 | Tono Vue Non-Contact Tonometer | Crystalvue Medical Corporation | 2018 | — |
| +3 | K253039 | Auto Kerato-Refracto Tonometer TRK-3 Omnia | Topcon Corporation | 2025 | — |
| +3 | K223739 | VS Tabletop Tonometer | Medimaging Integrated Solution, Inc. | 2023 | — |
| +1 | K073087 | Non-Contact Tonometer, Model FT-1000 | Tomey Corporation | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HKX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HKX device
- #1 K253039 Auto Kerato-Refracto Tonometer TRK-3 Omniascore 11.5 · 5 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K963079 | Canon TX-10 TonometerSummary page 1…Name: TX- 10 Tonometer Classification Name: 86HKX, Tonometer, AC powered Classification #: 886.1930 FDA 5 1O(k) #: K963079 Description Of Device: The Canon FULL AUTO TONOMETER TX-F is a tonometer designed using a non-contact measurement… | 1997 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K111710 (Canon Inc. -Medical Equipment Group, 2011) has gone furthest, with 3 descendants of its own.
How does its category compare?
All HKX devicesHKX Tonometer, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HKX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HKX
290in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HKX
No recall names HKX since 2007.
Adverse event reports per year · HKX
1in 2015
MAUDE reports naming product code HKX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 3 | 290 | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Canon FULL AUTO TONOMETER TX-F is intended to be used for the
measurement of intraocular pressure of the human eye.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023816 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023816: Canon Full Auto Tonometer TX-F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023816
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026