510(k) · Cleared
ClearedNon-Contact Tonometer T-2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canon, Inc. · HKX Tonometer, Ac-Powered
Cleared on May 12, 1995 after a 273-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 19 later devices descend from it.
- Decided
- May 12, 1995
- Review
- 273 days
- Class
- Class II
- Product code
- HKX
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 2 citing it directly.
- This deviceK943939 Non-Contact Tonometer T-2Canon, Inc. · 1995
- Descendant · cites it directly · 11 of its ownK021937 TGDC-01 PraTruevision Instruments · 2002
- Descendant · 2 generations on · 8 of its ownK063873 Icare Tonometer TA01ITiolat OY · 2007
- Descendant · cites it directly · 6 of its ownK963079 Canon TX-10 TonometerCanon USA, Inc. · 1997
- Descendant · 2 generations on · 5 of its ownK023816 Canon Full Auto Tonometer TX-FCanon, Inc.-Utsunomiya Optical Products Operation · 2002
- Descendant · 3 generations on · 4 of its ownK153694 Icare ic100Icare Finland OY · 2016
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K021937TGDC-01 PraTruevision Instruments · 2002 · cites it directly11descendants
- K063873Icare Tonometer TA01ITiolat OY · 2007 · 2 generations on8descendants
- K963079Canon TX-10 TonometerCanon USA, Inc. · 1997 · cites it directly6descendants
- K023816Canon Full Auto Tonometer TX-FCanon, Inc.-Utsunomiya Optical Products Operation · 2002 · 2 generations on5descendants
- K153694Icare ic100Icare Finland OY · 2016 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K943939 | Non-Contact Tonometer T-2 | Canon, Inc. | 1995 | — |
| +1 | K021937 | TGDC-01 Pra | Truevision Instruments | 2002 | — |
| +2 | K063873 | Icare Tonometer TA01I | Tiolat OY | 2007 | — |
| +1 | K963079 | Canon TX-10 Tonometer | Canon USA, Inc. | 1997 | — |
| +2 | K023816 | Canon Full Auto Tonometer TX-F | Canon, Inc.-Utsunomiya Optical Products Operation | 2002 | — |
| +3 | K153694 | Icare ic100 | Icare Finland OY | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (19)
See all 192 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?
- Of its descendants, K021937 (Truevision Instruments, 2002) has gone furthest, with 11 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 | — |
https://510kreport.com/device/K943939 · printed Nov 6, 2026
Cite this page
510(k) Report. “K943939: Non-Contact Tonometer T-2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943939
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026