510(k) · Cleared
ClearedKeeler Disposable Tonomate, Keeler Disposable Tonomate, Box of 100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Keeler Limited · HKY Tonometer, Manual
Cleared on Dec 31, 2015 as substantially equivalent to K093445 (Keeler, Ltd., 2010) and 2 other predicates after a 106-day review. Its family tree reaches back 4 generations to 1999.
- Decided
- Dec 31, 2015
- Review
- 106 days
- Class
- Class II
- Product code
- HKY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K981432 (1999). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK981432 Goldman Manual TonometerGolden Vision, Inc. · 1999
- 3 generations backK093445 Keeler Applanation Tonometer; T-Type Kat, K-Type Kat, (Kat)Keeler, Ltd. · 2010
- 2 generations backK133234 T-Type D-Kat, R-Type D-KatKeeler Limited · 2014
- 1 generation backK142179 D-Kat Z-YpeKeeler, Ltd. · 2014
- This deviceK152644 Keeler Disposable Tonomate, Keeler Disposable Tonomate, Box of 100Keeler Limited · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K981432 | Goldman Manual Tonometer | Golden Vision, Inc. | 1999 | — |
| −3 | 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 | — |
| −1 | K142179 | D-Kat Z-Ype | Keeler, Ltd. | 2014 | — |
| 0 (this device) | 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 |
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? (3)
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 |
|---|---|---|---|
| * | K093445 | Keeler Applanation Tonometer; T-Type Kat, K-Type Kat, (Kat)Summary page 5…eter with non-disposable (re-usable) Applanation Prism in the following original submissions: Keeler Applanation Tonometer T-Type KAT; R-Type KAT (K093445) Digital Keeler Applanation Tonometer D-KAT T-Type, D-KAT R-Type (K133234) 510(k) Keeler Tonomate… | 2010 |
| * | K133234 | T-Type D-Kat, R-Type D-KatSummary page 5…inal submissions: Keeler Applanation Tonometer T-Type KAT; R-Type KAT (K093445) Digital Keeler Applanation Tonometer D-KAT T-Type, D-KAT R-Type (K133234) 510(k) Keeler Tonomate Page 2 of 3… | 2014 |
| * | K142179 | D-Kat Z-YpeSummary page 6…er Tonomate Page 2 of 3 Digital Keeler Applanation Tonometer D-KAT Z-Type (K142179) 1.6 Summary of Design Control Activities In accordance with FDA guidance on submission of a Special 510(k), risk… | 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 16 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K093445.
How does its category compare?
All HKY devicesHKY Tonometer, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 and Digital Keeler Applanation Tonometer are 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/K152644 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152644: Keeler Disposable Tonomate, Keeler Disposable Tonomate, Box of 100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152644
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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