510(k) · Cleared
ClearedApplanation Tonometer HT-5000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Huvitz Co., Ltd. · HKY Tonometer, Manual
Cleared on Oct 23, 2023 as substantially equivalent to K133234 (Keeler Limited, 2014) after a 96-day review. Its family tree reaches back 3 generations to 1999.
- Decided
- Oct 23, 2023
- Review
- 96 days
- Class
- Class II
- Product code
- HKY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K981432 (1999). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK981432 Goldman Manual TonometerGolden Vision, Inc. · 1999
- 2 generations backK093445 Keeler Applanation Tonometer; T-Type Kat, K-Type Kat, (Kat)Keeler, Ltd. · 2010
- 1 generation backK133234 T-Type D-Kat, R-Type D-KatKeeler Limited · 2014
- This deviceK232143 Applanation Tonometer HT-5000Huvitz Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K981432 | Goldman Manual Tonometer | Golden Vision, Inc. | 1999 | — |
| −2 | K093445 | Keeler Applanation Tonometer; T-Type Kat, K-Type Kat, (Kat) | Keeler, Ltd. | 2010 | — |
| −1 | K133234 | T-Type D-Kat, R-Type D-Kat | Keeler Limited | 2014 | — |
| 0 (this device) | K232143 | Applanation Tonometer HT-5000 | Huvitz Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 HKY? 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 HKY device
- #1 K241447 iCare ST500 (TA04)score 9.6 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K133234 | T-Type D-Kat, R-Type D-KatSummary page 5…Code: HKY - Review Panel: Ophthalmic Predicate Device Information: - 510(k) Number: K133234 - Trade Name: Digital Keeler Applanation Tonometer (D-KAT) - Proprietary Name:… | 2014 |
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 24 years and passes through 4 companies; a new generation was cleared every 9.7 years on median.
- None of the 4 ancestors has a recall.
- 3 other devices also cite its predicate K133234.
How does its category compare?
All HKY devicesHKY Tonometer, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · HKY
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HKY
128in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HKY
2in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HKY
1in 2019
MAUDE reports naming product code HKY, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 3 | 123 | 2 | 3 |
| 2015 | 2 | — | 0 | 1 |
| 2016 | 3 | 226 | 0 | 2 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 3 | 77 | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 3 | 128 | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Applanation Tonometer HT-5000 is a manual device intended to measure an intraocular pressure by applanation to aid in the diagnosis of glaucoma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232143 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232143: Applanation Tonometer HT-5000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232143
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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