510(k) · Cleared
ClearedSensor Medical Single Use Tonometer Prism
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sensor Medical Technology, LLC · HKY Tonometer, Manual
Cleared on Oct 13, 2015 as substantially equivalent to K023838 (Luneau SA, 2003) after a 60-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Oct 13, 2015
- Review
- 60 days
- Class
- Class II
- Product code
- HKY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K023838 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK023838 Luneau Sterile Tonometer Separation PrismsLuneau SA · 2003
- This deviceK152308 Sensor Medical Single Use Tonometer PrismSensor Medical Technology, LLC · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K023838 | Luneau Sterile Tonometer Separation Prisms | Luneau SA | 2003 | — |
| 0 (this device) | K152308 | Sensor Medical Single Use Tonometer Prism | Sensor Medical Technology, LLC | 2015 | — |
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 |
|---|---|---|---|
| * | K023838 | Luneau Sterile Tonometer Separation PrismsSummary page 4…al Name Tonometer Prism Classification Name and Regulation Manual Tonometer 21 CFR 886.1930, HKY Ophthalmic Panel Predicate Devices Luneau Tonometer Separation Prisms (K023838) Intended Use / Indications for Use The Sensor Medical Single Use Tonometer Prism is intended for use as a disposable applanatin… | 2003 |
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?
- Its one ancestor has no recall.
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 Sensor Medical Single Use Tonometer Prism is intended for use as a disposable applanating and optical doubling prism for Goldmann style applanation tonometers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152308 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152308: Sensor Medical Single Use Tonometer Prism.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152308
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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