510(k) · Cleared
ClearediCare ST500 (TA04)
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 Sep 27, 2024 as substantially equivalent to K220852 (Icare Finland OY, 2022) after a 128-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Sep 27, 2024
- Review
- 128 days
- Class
- Class II
- Product code
- HKY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K943939 (1995). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK943939 Non-Contact Tonometer T-2Canon, Inc. · 1995
- 5 generations backK021937 TGDC-01 PraTruevision Instruments · 2002
- 4 generations backK063873 Icare Tonometer TA01ITiolat OY · 2007
- 3 generations backK153694 Icare ic100Icare Finland OY · 2016
- 2 generations backK190316 Icare ic200Icare Finland OY · 2020
- 1 generation backK220852 iCare IC200Icare Finland OY · 2022
- This deviceK241447 iCare ST500 (TA04)Icare Finland OY · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K943939 | Non-Contact Tonometer T-2 | Canon, Inc. | 1995 | — |
| −5 | K021937 | TGDC-01 Pra | Truevision Instruments | 2002 | — |
| −4 | K063873 | Icare Tonometer TA01I | Tiolat OY | 2007 | — |
| −3 | K153694 | Icare ic100 | Icare Finland OY | 2016 | — |
| −2 | K190316 | Icare ic200 | Icare Finland OY | 2020 | — |
| −1 | K220852 | iCare IC200 | Icare Finland OY | 2022 | — |
| 0 (this device) | 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 |
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 K220852 iCare IC200score 8.3 · 5 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 |
|---|---|---|---|
| * | K220852 | iCare IC200Summary page 5…HKY, HKX Premarket Notification 510(k) Number: K241447 This premarket notification type is Traditional 510(k). 1.3 Legally Marketed Predicate Devices Predicate #: K220852 Predicate Trade Name (Primary Predicate is listed first): iCare IC200 (TA031) Product Code: HKY 1.4 Device Description Summary… | 2022 |
| † | K211355 | iCare HOME2 | 2022 |
| † | K190316 | Icare ic200 | 2020 |
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 29 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- None of the 10 ancestors has a recall.
How does its category compare?
All HKY devicesHKY Tonometer, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 ST500 tonometer is a device intended to be used for the measurement of the intraocular pressure of the human eye.
The iCare ST500 tonometer is intended to be used by healthcare professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241447 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241447: iCare ST500 (TA04).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241447
Report an extraction error
Are you the manufacturer?
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