510(k) · Cleared
ClearedIcare ic200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icare Finland OY · HKY Tonometer, Manual
Cleared on Jan 14, 2020 as substantially equivalent to K153694 (Icare Finland OY, 2016) after a 335-day review. Its family tree reaches back 4 generations to 1995. 2 later devices descend from it.
- Decided
- Jan 14, 2020
- Review
- 335 days
- Class
- Class II
- Product code
- HKY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K943939 (1995). 8 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK943939 Non-Contact Tonometer T-2Canon, Inc. · 1995
- 3 generations backK021937 TGDC-01 PraTruevision Instruments · 2002
- 2 generations backK063873 Icare Tonometer TA01ITiolat OY · 2007
- 1 generation backK153694 Icare ic100Icare Finland OY · 2016
- This deviceK190316 Icare ic200Icare Finland OY · 2020
- Descendant · cites it directly · 1 of its ownK220852 iCare IC200Icare Finland OY · 2022
- Descendant · 2 generations on · 0 of its ownK241447 iCare ST500 (TA04)Icare Finland OY · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K943939 | Non-Contact Tonometer T-2 | Canon, Inc. | 1995 | — |
| −3 | K021937 | TGDC-01 Pra | Truevision Instruments | 2002 | — |
| −2 | K063873 | Icare Tonometer TA01I | Tiolat OY | 2007 | — |
| −1 | K153694 | Icare ic100 | Icare Finland OY | 2016 | — |
| 0 (this device) | K190316 | Icare ic200 | Icare Finland OY | 2020 | — |
| +1 | K220852 | iCare IC200 | Icare Finland OY | 2022 | — |
| +2 | K241447 | iCare ST500 (TA04) | Icare Finland OY | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K153694 | Icare ic100Summary page 4…phthalmic Product Code: HKY Premarket Notification (510(k)) Number: K190316 III. PREDICATE DEVICE Icare ic100 tonometer (type TA011), K153694 This predicate has not been subject to a design-related recall. IV. INDICATIONS FOR USE / INTENDED USE “The Icare ic200 to… | 2016 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220852 | iCare IC200 | 2022 | 1 |
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 25 years and passes through 4 companies; a new generation was cleared every 7.4 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K220852 (Icare Finland OY, 2022) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K153694.
How does its category compare?
All HKY devicesHKY Tonometer, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Icare ic200 tonometer is intended to be used for the measurement of intraocular pressure of the human eye.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190316 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190316: Icare ic200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190316
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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