510(k) · Cleared
ClearedKeeler Applanation Tonometer; T-Type Kat, K-Type Kat, (Kat)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Keeler, Ltd. · HKY Tonometer, Manual
Cleared on Jan 19, 2010 as substantially equivalent to K022054 (C.S.O. S.R.L., 2002) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1999. 5 later devices descend from it.
- Decided
- Jan 19, 2010
- Review
- 90 days
- Class
- Class II
- Product code
- HKY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K981432 (1999). 2 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK981432 Goldman Manual TonometerGolden Vision, Inc. · 1999
- This deviceK093445 Keeler Applanation Tonometer; T-Type Kat, K-Type Kat, (Kat)Keeler, Ltd. · 2010
- Descendant · cites it directly · 4 of its ownK133234 T-Type D-Kat, R-Type D-KatKeeler Limited · 2014
- Descendant · 2 generations on · 2 of its ownK142179 D-Kat Z-YpeKeeler, Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK232143 Applanation Tonometer HT-5000Huvitz Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK191314 Sunkingdom Applanation Tonometer SK-R, SK-T, SK-QChongqing Sunkingdom Medical Instrument Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK152644 Keeler Disposable Tonomate, Keeler Disposable Tonomate, Box of 100Keeler Limited · 2015
Most influential descendants
Showing 5 of 5 · See all- K133234T-Type D-Kat, R-Type D-KatKeeler Limited · 2014 · cites it directly4descendants
- K142179D-Kat Z-YpeKeeler, Ltd. · 2014 · 2 generations on2descendants
- K232143Applanation Tonometer HT-5000Huvitz Co., Ltd. · 2023 · 2 generations on0descendants
- K191314Sunkingdom Applanation Tonometer SK-R, SK-T, SK-QChongqing Sunkingdom Medical Instrument Co., Ltd. · 2019 · 2 generations on0descendants
- K152644Keeler Disposable Tonomate, Keeler Disposable Tonomate, Box of 100Keeler Limited · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981432 | Goldman Manual Tonometer | Golden Vision, Inc. | 1999 | — |
| 0 (this device) | 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 | — |
| +2 | K142179 | D-Kat Z-Ype | Keeler, Ltd. | 2014 | — |
| +2 | K232143 | Applanation Tonometer HT-5000 | Huvitz Co., Ltd. | 2023 | — |
| +2 | K191314 | Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 2019 | — |
| +1 | K152644 | Keeler Disposable Tonomate, Keeler Disposable Tonomate, Box of 100 | Keeler Limited | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K022054 | F 900Summary page 2…eness and intended use to the following legally marketed devices: Substantial Equivalence 1:, Predicate Device: F900 and A900, 080 510(k No: K022054 Manufacturer: 080 S.R.L Substantial Equivalence 2: Predicate Device: Haag Streit AT 900 510(k) No:… | 2002 |
| * | K981432 | Goldman Manual TonometerSummary page 2…No: K022054 Manufacturer: 080 S.R.L Substantial Equivalence 2: Predicate Device: Haag Streit AT 900 510(k) No: K981432 Manufacturer: Haag-Streit Substantial Equivalence Comparison Table below shows the comparison of Keeler Applanation… | 1999 |
What descends from it? (5)
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K133234 (Keeler Limited, 2014) has gone furthest, with 4 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. 2010, 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 Keeler Applanation Tonometer is indicated for measuring intraocular pressure to aid in the screening and diagnosis of Glaucoma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093445 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093445: Keeler Applanation Tonometer; T-Type Kat, K-Type Kat, (Kat).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093445
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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