Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Icare Finland OY · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
128 daysmedian FDA review time
335 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241447 | iCare ST500 (TA04) | Icare Finland OY | 2024-09-27 | 128 | 0 |
| K220852 | iCare IC200 | Icare Finland OY | 2022-10-06 | 197 | 0 |
| K211355 | iCare HOME2 | Icare Finland OY | 2022-01-25 | 267 | 0 |
| K200966 | Icare HOME Tonometer | Icare Finland OY | 2020-05-07 | 27 | 0 |
| K190316 | Icare ic200 | Icare Finland OY | 2020-01-14 | 335 | 0 |
| K163343 | Icare HOME tonometer | Icare Finland OY | 2017-03-21 | 112 | 0 |
| K153694 | Icare ic100 | Icare Finland OY | 2016-04-19 | 118 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda