510(k) · Cleared
ClearedAuto Kerato-Refracto Tonometer TRK-3 Omnia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Topcon Corporation · HKX Tonometer, Ac-Powered
Cleared on Nov 7, 2025 as substantially equivalent to K180820 (Crystalvue Medical Corporation, 2018) and 1 other predicate after a 46-day review. Its family tree reaches back 5 generations to 1992.
- Decided
- Nov 7, 2025
- Review
- 46 days
- Class
- Class II
- Product code
- HKX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K920906 (1992). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK920906 DGH-500 PachymeterDgh Technology, Inc. · 1992
- 4 generations backK980357 Konan Noncon Robo Pachy Specular Microscope and Opticl PachymeterKonan, Inc. · 1998
- 3 generations backK062763 Noncon Robo Pachy F&aKonan Medical, Inc. · 2008
- 2 generations backK120264 Konan Specular Microscope XivKonan Medical, Inc. · 2012
- 1 generation backK142417 SP-1PSpecular MicroscopeTopcon Corporation · 2015
- This deviceK253039 Auto Kerato-Refracto Tonometer TRK-3 OmniaTopcon Corporation · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K920906 | DGH-500 Pachymeter | Dgh Technology, Inc. | 1992 | — |
| −4 | K980357 | Konan Noncon Robo Pachy Specular Microscope and Opticl Pachymeter | Konan, Inc. | 1998 | — |
| −3 | K062763 | Noncon Robo Pachy F&a | Konan Medical, Inc. | 2008 | — |
| −2 | K120264 | Konan Specular Microscope Xiv | Konan Medical, Inc. | 2012 | — |
| −1 | K142417 | SP-1PSpecular Microscope | Topcon Corporation | 2015 | — |
| 0 (this device) | K253039 | Auto Kerato-Refracto Tonometer TRK-3 Omnia | Topcon Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2011 | 1 | 0 |
| 2018 | 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 K223739 VS Tabletop Tonometerscore 7.5 · 5 generations · no Class I recall
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 |
|---|---|---|---|
| * | K180820 | Tono Vue Non-Contact TonometerSummary page 6…K253039 PRIMARY PREDICATE DEVICE Company: TonoVue Non-Contact Tonometer Device: Crystalvue Medical Corporation 510(k) No.: K180820 Classification Name: 21 CFR §886.1930 (Tonometer and accessories) Product Code: HKX (Tonometer, Ac-Powered) SECON… | 2018 |
| * | K142417 | SP-1PSpecular MicroscopeSummary page 6…HKX (Tonometer, Ac-Powered) SECONDARY PREDICATE DEVICE Company: TOPCON CORPORATION Device: SP-1P Specular Microscope 510(k) No.: K142417 Classification Name: 21 CFR §886.1850 (AC Powered Slit Lamp Biomicroscope) Product Code: NQE (Microscope, Specular) BRI… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 33 years and passes through 4 companies; a new generation was cleared every 5.5 years on median.
- None of the 11 ancestors has a recall.
- 1 other device also cites its predicate K180820.
How does its category compare?
All HKX devicesHKX Tonometer, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
TRK-3 OMNIA is a combination of the non-contact tonometer and pachymeter. The device is indicated for automatic measurement of intraocular pressure without contacting the eye (with less than 3 diopters of corneal astigmatism); and measurement of central corneal thickness.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253039 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253039: Auto Kerato-Refracto Tonometer TRK-3 Omnia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253039
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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