510(k) · Cleared
ClearedGoldman Manual Tonometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Golden Vision, Inc. · HKY Tonometer, Manual
Cleared on Jan 12, 1999 after a 267-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 25 later devices descend from it.
- Decided
- Jan 12, 1999
- Review
- 267 days
- Class
- Class II
- Product code
- HKY
- Recalls
- None
- Predicates
- 0
25 later devices descend from it, 10 citing it directly.
- This deviceK981432 Goldman Manual TonometerGolden Vision, Inc. · 1999
- Descendant · cites it directly · 11 of its ownK021937 TGDC-01 PraTruevision Instruments · 2002
- Descendant · cites it directly · 8 of its ownK063873 Icare Tonometer TA01ITiolat OY · 2007
- Descendant · cites it directly · 5 of its ownK093445 Keeler Applanation Tonometer; T-Type Kat, K-Type Kat, (Kat)Keeler, Ltd. · 2010
- Descendant · 2 generations on · 4 of its ownK153694 Icare ic100Icare Finland OY · 2016
- Descendant · 2 generations on · 4 of its ownK133234 T-Type D-Kat, R-Type D-KatKeeler Limited · 2014
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K021937TGDC-01 PraTruevision Instruments · 2002 · cites it directly11descendants
- K063873Icare Tonometer TA01ITiolat OY · 2007 · cites it directly8descendants
- K093445Keeler Applanation Tonometer; T-Type Kat, K-Type Kat, (Kat)Keeler, Ltd. · 2010 · cites it directly5descendants
- K153694Icare ic100Icare Finland OY · 2016 · 2 generations on4descendants
- K133234T-Type D-Kat, R-Type D-KatKeeler Limited · 2014 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981432 | Goldman Manual Tonometer | Golden Vision, Inc. | 1999 | — |
| +1 | K021937 | TGDC-01 Pra | Truevision Instruments | 2002 | — |
| +1 | K063873 | Icare Tonometer TA01I | Tiolat OY | 2007 | — |
| +1 | K093445 | Keeler Applanation Tonometer; T-Type Kat, K-Type Kat, (Kat) | Keeler, Ltd. | 2010 | — |
| +2 | K153694 | Icare ic100 | Icare Finland OY | 2016 | — |
| +2 | K133234 | T-Type D-Kat, R-Type D-Kat | Keeler Limited | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (25)
See all 2510 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021937 | TGDC-01 Pra | 2002 | 11 |
| K063873 | Icare Tonometer TA01I | 2007 | 8 |
| K093445 | Keeler Applanation Tonometer; T-Type Kat, K-Type Kat, (Kat) | 2010 | 5 |
| K173904 | CATS Tonometer Prism | 2018 | 2 |
| K163343 | Icare HOME tonometer | 2017 | 2 |
| K071755 | Falck Applanation Tonometer (FAT2) | 2008 | 1 |
| K060780 | Tonometer Diaton | 2006 | 1 |
| K234037 | CATS-L Tonometer™ Prism | 2024 | 0 |
| K180839 | AT 030 | 2018 | 0 |
| K172728 | Applanation tonometer AT-1 | 2017 | 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?
- Of its descendants, K021937 (Truevision Instruments, 2002) has gone furthest, with 11 descendants of its own.
How does its category compare?
All HKY devicesHKY Tonometer, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 GOLDMAN MANUAL TONOMETER IS AN APPLIANCE THAT SERVES TO MEASURE INTRAOCULAR PRESSURE, ACCORDING TO THE GOLDMAN METHOD. THE MEASURING OF THE PRESSURE REQUIRES TO MAINTAIN A UNIFORM APPLANATION OF THE SURFACE OF THE CORNEA.
IT IS SPECIALLY INDICATED IN GLAUCOMA DISEASE.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981432 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981432: Goldman Manual Tonometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981432
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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