510(k) · Cleared
ClearedF 900
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.S.O. S.R.L. · HKY Tonometer, Manual
Cleared on Aug 6, 2002 after a 43-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.
- Decided
- Aug 6, 2002
- Review
- 43 days
- Class
- Class II
- Product code
- HKY
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK022054 F 900C.S.O. S.R.L. · 2002
- 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 ownK133234 T-Type D-Kat, R-Type D-KatKeeler Limited · 2014
- Descendant · 3 generations on · 2 of its ownK142179 D-Kat Z-YpeKeeler, Ltd. · 2014
- Descendant · 3 generations on · 0 of its ownK232143 Applanation Tonometer HT-5000Huvitz Co., Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK191314 Sunkingdom Applanation Tonometer SK-R, SK-T, SK-QChongqing Sunkingdom Medical Instrument Co., Ltd. · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K093445Keeler Applanation Tonometer; T-Type Kat, K-Type Kat, (Kat)Keeler, Ltd. · 2010 · cites it directly5descendants
- K133234T-Type D-Kat, R-Type D-KatKeeler Limited · 2014 · 2 generations on4descendants
- K142179D-Kat Z-YpeKeeler, Ltd. · 2014 · 3 generations on2descendants
- K232143Applanation Tonometer HT-5000Huvitz Co., Ltd. · 2023 · 3 generations on0descendants
- K191314Sunkingdom Applanation Tonometer SK-R, SK-T, SK-QChongqing Sunkingdom Medical Instrument Co., Ltd. · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022054 | F 900 | C.S.O. S.R.L. | 2002 | — |
| +1 | K093445 | Keeler Applanation Tonometer; T-Type Kat, K-Type Kat, (Kat) | Keeler, Ltd. | 2010 | — |
| +2 | K133234 | T-Type D-Kat, R-Type D-Kat | Keeler Limited | 2014 | — |
| +3 | K142179 | D-Kat Z-Ype | Keeler, Ltd. | 2014 | — |
| +3 | K232143 | Applanation Tonometer HT-5000 | Huvitz Co., Ltd. | 2023 | — |
| +3 | K191314 | Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 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? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093445 | Keeler Applanation Tonometer; T-Type Kat, K-Type Kat, (Kat) | 2010 | 5 |
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, K093445 (Keeler, Ltd., 2010) has gone furthest, with 5 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?
A manual device intended to measure intraocular pressure by applanation (applying a small flat disk to the cornea)
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K022054 · printed Nov 5, 2026
Cite this page
510(k) Report. “K022054: F 900.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022054
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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