510(k) · Cleared
ClearedCanon TX-10 Tonometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canon USA, Inc. · HKX Tonometer, Ac-Powered
Cleared on Mar 3, 1997 as substantially equivalent to K943939 (Canon, Inc., 1995) after a 208-day review. Its family tree reaches back 1 generation to 1995. 6 later devices descend from it.
- Decided
- Mar 3, 1997
- Review
- 208 days
- Class
- Class II
- Product code
- HKX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K943939 (1995). 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK943939 Non-Contact Tonometer T-2Canon, Inc. · 1995
- This deviceK963079 Canon TX-10 TonometerCanon USA, Inc. · 1997
- Descendant · cites it directly · 5 of its ownK023816 Canon Full Auto Tonometer TX-FCanon, Inc.-Utsunomiya Optical Products Operation · 2002
- Descendant · 2 generations on · 3 of its ownK111710 Full Auto Tonometer Model TX-20Canon Inc. -Medical Equipment Group · 2011
- Descendant · 3 generations on · 2 of its ownK180820 Tono Vue Non-Contact TonometerCrystalvue Medical Corporation · 2018
- Descendant · 4 generations on · 0 of its ownK253039 Auto Kerato-Refracto Tonometer TRK-3 OmniaTopcon Corporation · 2025
- Descendant · 4 generations on · 0 of its ownK223739 VS Tabletop TonometerMedimaging Integrated Solution, Inc. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K023816Canon Full Auto Tonometer TX-FCanon, Inc.-Utsunomiya Optical Products Operation · 2002 · cites it directly5descendants
- K111710Full Auto Tonometer Model TX-20Canon Inc. -Medical Equipment Group · 2011 · 2 generations on3descendants
- K180820Tono Vue Non-Contact TonometerCrystalvue Medical Corporation · 2018 · 3 generations on2descendants
- K253039Auto Kerato-Refracto Tonometer TRK-3 OmniaTopcon Corporation · 2025 · 4 generations on0descendants
- K223739VS Tabletop TonometerMedimaging Integrated Solution, Inc. · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K943939 | Non-Contact Tonometer T-2 | Canon, Inc. | 1995 | — |
| 0 (this device) | K963079 | Canon TX-10 Tonometer | Canon USA, Inc. | 1997 | — |
| +1 | K023816 | Canon Full Auto Tonometer TX-F | Canon, Inc.-Utsunomiya Optical Products Operation | 2002 | — |
| +2 | K111710 | Full Auto Tonometer Model TX-20 | Canon Inc. -Medical Equipment Group | 2011 | — |
| +3 | K180820 | Tono Vue Non-Contact Tonometer | Crystalvue Medical Corporation | 2018 | — |
| +4 | K253039 | Auto Kerato-Refracto Tonometer TRK-3 Omnia | Topcon Corporation | 2025 | — |
| +4 | K223739 | VS Tabletop Tonometer | Medimaging Integrated Solution, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K943939 | Non-Contact Tonometer T-2Summary page 1…516) 328-5169 Canon TX-10 Tonometer 86HKX, 1'onometer, AC Powered Document Control Number: ? Canon T-2 Tonometer 86HKX, T'onometer, AC Powered Document Control Number: K943939 The TX-10 is a tonometer designed using a non-contact measurement system. Air puff gently measures the intraocular pressure with… | 1995 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023816 | Canon Full Auto Tonometer TX-F | 2002 | 5 |
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?
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 TX-10 tonometer is intended to be used for the measurement of intraocular pressure of the human eye.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K963079 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963079: Canon TX-10 Tonometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963079
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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