510(k) · Cleared
ClearedTono Vue Non-Contact Tonometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Crystalvue Medical Corporation · HKX Tonometer, Ac-Powered
Cleared on Dec 14, 2018 as substantially equivalent to K111710 (Canon Inc. -Medical Equipment Group, 2011) after a 260-day review. Its family tree reaches back 4 generations to 1995. 2 later devices descend from it.
- Decided
- Dec 14, 2018
- Review
- 260 days
- Class
- Class II
- Product code
- HKX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K943939 (1995). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK943939 Non-Contact Tonometer T-2Canon, Inc. · 1995
- 3 generations backK963079 Canon TX-10 TonometerCanon USA, Inc. · 1997
- 2 generations backK023816 Canon Full Auto Tonometer TX-FCanon, Inc.-Utsunomiya Optical Products Operation · 2002
- 1 generation backK111710 Full Auto Tonometer Model TX-20Canon Inc. -Medical Equipment Group · 2011
- This deviceK180820 Tono Vue Non-Contact TonometerCrystalvue Medical Corporation · 2018
- Descendant · cites it directly · 0 of its ownK253039 Auto Kerato-Refracto Tonometer TRK-3 OmniaTopcon Corporation · 2025
- Descendant · cites it directly · 0 of its ownK223739 VS Tabletop TonometerMedimaging Integrated Solution, Inc. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K943939 | Non-Contact Tonometer T-2 | Canon, Inc. | 1995 | — |
| −3 | K963079 | Canon TX-10 Tonometer | Canon USA, Inc. | 1997 | — |
| −2 | 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 | — |
| 0 (this device) | K180820 | Tono Vue Non-Contact Tonometer | Crystalvue Medical Corporation | 2018 | — |
| +1 | K253039 | Auto Kerato-Refracto Tonometer TRK-3 Omnia | Topcon Corporation | 2025 | — |
| +1 | K223739 | VS Tabletop Tonometer | Medimaging Integrated Solution, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K111710 | Full Auto Tonometer Model TX-20Summary page 5…21 CFR § 886.1930 Predicate Devices Trade Name: Canon Full Auto Tonometer TX-20. Classification Name: HKX, Tonometer and accessories 510(k) Number: K111710 Intended Use The TonoVue is a non-contact tonometer that is intended to measure the intraocular pressure of the human… | 2011 |
What descends from it? (2)
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 23 years and passes through 5 companies; a new generation was cleared every 7.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K253039 (Topcon Corporation, 2025) has gone furthest, with 0 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. 2018, this device’s year, is highlighted.
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 TonoVue is a non-contact tonometer that intended to measure the intra-ocular pressure of the eye in patients with less than 3 diopters of corneal astigmatism.
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/K180820 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180820: Tono Vue Non-Contact Tonometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180820
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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