510(k) · Cleared
ClearedTonometer Diaton
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ryazan State Instruments · HKX Tonometer, Ac-Powered
Cleared on Apr 6, 2006 as substantially equivalent to K981432 (Golden Vision, Inc., 1999) and 1 other predicate after a 15-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.
- Decided
- Apr 6, 2006
- Review
- 15 days
- Class
- Class II
- Product code
- HKX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K943939 (1995). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK943939 Non-Contact Tonometer T-2Canon, Inc. · 1995
- 1 generation backK021937 TGDC-01 PraTruevision Instruments · 2002
- This deviceK060780 Tonometer DiatonRyazan State Instruments · 2006
- Descendant · cites it directly · 0 of its ownK190382 Intraocular Pressure Tonometer EASYTONCompany Elamed · 2019
Most influential descendants
Showing 1 of 1 · See all- K190382Intraocular Pressure Tonometer EASYTONCompany Elamed · 2019 · 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 | K021937 | TGDC-01 Pra | Truevision Instruments | 2002 | — |
| 0 (this device) | K060780 | Tonometer Diaton | Ryazan State Instruments | 2006 | — |
| +1 | K190382 | Intraocular Pressure Tonometer EASYTON | Company Elamed | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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? (2)
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 |
|---|---|---|---|
| * | K981432 | Goldman Manual TonometerSummary page 2…ed devices: Goldman Manual Tonometer 510(k) Number: Golden Vision, Inc.) K981432 TGDc-01 "PRA" 510(k) Number: (Truevision Instruments)… | 1999 |
| * | K021937 | TGDC-01 PraSummary page 2…K981432 TGDc-01 "PRA" 510(k) Number: (Truevision Instruments) K021937 2.2. Intended Use Quick and accurate measurement of IOP in various situations independent of place and time is the dream of e… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190382 | Intraocular Pressure Tonometer EASYTON | 2019 | 0 |
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 11 years and passes through 3 companies; a new generation was cleared every 7.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K190382 (Company Elamed, 2019) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K981432.
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 Diaton Tonometer is intended to measure intraocular pressure (lOP). The device is intended for use as an aid in the diagnosis of glaucoma and for monitoring 10IP
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060780 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060780: Tonometer Diaton.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060780
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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