510(k) · Cleared
ClearediCare HOME2
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 25, 2022 as substantially equivalent to K200966 (Icare Finland OY, 2020) after a 267-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Jan 25, 2022
- Review
- 267 days
- Class
- Class II
- Product code
- HKY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K943939 (1995). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK943939 Non-Contact Tonometer T-2Canon, Inc. · 1995
- 4 generations backK021937 TGDC-01 PraTruevision Instruments · 2002
- 3 generations backK063873 Icare Tonometer TA01ITiolat OY · 2007
- 2 generations backK163343 Icare HOME tonometerIcare Finland OY · 2017
- 1 generation backK200966 Icare HOME TonometerIcare Finland OY · 2020
- This deviceK211355 iCare HOME2Icare Finland OY · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K943939 | Non-Contact Tonometer T-2 | Canon, Inc. | 1995 | — |
| −4 | K021937 | TGDC-01 Pra | Truevision Instruments | 2002 | — |
| −3 | K063873 | Icare Tonometer TA01I | Tiolat OY | 2007 | — |
| −2 | K163343 | Icare HOME tonometer | Icare Finland OY | 2017 | — |
| −1 | K200966 | Icare HOME Tonometer | Icare Finland OY | 2020 | — |
| 0 (this device) | K211355 | iCare HOME2 | Icare Finland OY | 2022 | — |
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 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 |
|---|---|---|---|
| * | K200966 | Icare HOME TonometerSummary page 4…510(k) Number: K211355 This premarket notification type is Traditional 510(k). 1.3 Predicate and Reference Device Primary predicate: iCare HOME tonometer (type TA022), K200966 Reference device: iCare IC200 tonometer (type TA031), K190316. The predicate device and the reference device have not been subjec… | 2020 |
| † | 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 27 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- None of the 9 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. 2022, 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 HOME2 tonometer is a prescription device intended as an adjunct to the routine clinical monitoring of intraocular pressure (IOP) of adult patients.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211355 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211355: iCare HOME2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211355
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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