510(k) · Cleared
ClearedPascal Dynamic Contour Tonometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smt Swiss Microtechnology AG · HKY Tonometer, Manual
Cleared on Nov 14, 2003 after a 52-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 9 later devices descend from it.
- Decided
- Nov 14, 2003
- Review
- 52 days
- Class
- Class II
- Product code
- HKY
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 1 citing it directly.
- This deviceK032967 Pascal Dynamic Contour TonometerSmt Swiss Microtechnology AG · 2003
- Descendant · cites it directly · 8 of its ownK063873 Icare Tonometer TA01ITiolat OY · 2007
- Descendant · 2 generations on · 4 of its ownK153694 Icare ic100Icare Finland OY · 2016
- Descendant · 3 generations on · 2 of its ownK190316 Icare ic200Icare Finland OY · 2020
- Descendant · 2 generations on · 2 of its ownK163343 Icare HOME tonometerIcare Finland OY · 2017
- Descendant · 4 generations on · 1 of its ownK220852 iCare IC200Icare Finland OY · 2022
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K063873Icare Tonometer TA01ITiolat OY · 2007 · cites it directly8descendants
- K153694Icare ic100Icare Finland OY · 2016 · 2 generations on4descendants
- K190316Icare ic200Icare Finland OY · 2020 · 3 generations on2descendants
- K163343Icare HOME tonometerIcare Finland OY · 2017 · 2 generations on2descendants
- K220852iCare IC200Icare Finland OY · 2022 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032967 | Pascal Dynamic Contour Tonometer | Smt Swiss Microtechnology AG | 2003 | — |
| +1 | K063873 | Icare Tonometer TA01I | Tiolat OY | 2007 | — |
| +2 | K153694 | Icare ic100 | Icare Finland OY | 2016 | — |
| +3 | K190316 | Icare ic200 | Icare Finland OY | 2020 | — |
| +2 | K163343 | Icare HOME tonometer | Icare Finland OY | 2017 | — |
| +4 | K220852 | iCare IC200 | Icare Finland OY | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 2 | 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? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063873 | Icare Tonometer TA01I | 2007 | 8 |
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, K063873 (Tiolat OY, 2007) has gone furthest, with 8 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 PASCALTM Dynamic Contour Tonometer is a diagnostic device that serves for measuring intraocular pressure (IOP), according to the Contour Tonometry method. The device is also capable of measuring short term pressure fluctuations.
PASCALTM is specially indicated in Glaucoma.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K032967 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032967: Pascal Dynamic Contour Tonometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032967
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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