Icare Finland OY: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Icare Finland OY” (first 2016, latest 2024), across 1 product code in 1 review panel. Median 510(k) review time under this name: 128 days. Since 2017 the median was 162 days, against 112 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 118 |
| 2017 | 1 | 112 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 2 | 181 |
| 2021 | 0 | — |
| 2022 | 2 | 232 |
| 2023 | 0 | — |
| 2024 | 1 | 128 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Icare Finland OY took a median 162 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HKY | Tonometer, Manual | 7 | 7 |
Review panels
- Ophthalmic (7)
Most recent Icare Finland OY 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241447 | iCare ST500 (TA04) | HKY | 2024-09-27 | 128 |
| K220852 | iCare IC200 | HKY | 2022-10-06 | 197 |
| K211355 | iCare HOME2 | HKY | 2022-01-25 | 267 |
| K200966 | Icare HOME Tonometer | HKY | 2020-05-07 | 27 |
| K190316 | Icare ic200 | HKY | 2020-01-14 | 335 |
| K163343 | Icare HOME tonometer | HKY | 2017-03-21 | 112 |
| K153694 | Icare ic100 | HKY | 2016-04-19 | 118 |
Recalls
openFDA lists no recalls under a recalling firm named Icare Finland OY.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Icare Finland OY is the lead sponsor of 6 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT06748092: Clinical Validation of iCare IC1000 Tonometer (Completed, started 2025-10-21)
- NCT07156630: Quick Measure Study for iCare ST500 and iCare IC200 (Completed, started 2025-08-28)
- NCT07022054: iCare IC1000 Alignment Study (Completed, started 2025-05-22)
- NCT06450587: Intraocular Pressure Data Collection With Tonometers (Completed, started 2024-05-29)
- NCT05742009: iCare ST500 Clinical Trial (Completed, started 2023-06-05)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Icare Newlife Technologies, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Icare Finland OY?
FDA lists 7 510(k) clearances under the applicant name “Icare Finland OY” (first 2016, latest 2024), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Icare Finland OY?
The median time from FDA receipt to decision across 510(k)s cleared under the name Icare Finland OY is 128 days. Since 2017: 162 days, versus 112 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Icare Finland OY?
The most frequent FDA product codes under this applicant name are HKY (Tonometer, Manual, 7).
Next steps
- See all 7 Icare Finland OY clearances with predicates and recalls
- Run predicate analysis for product code HKY, Icare Finland OY's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.