Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ikonisys, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K080909 | ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000 | Ikonisys, Inc. | 2008-10-17 | 199 | 0 |
| K062755 | IKONISCOPE ONCOFISH BLADDER TEST SYSTEM | Ikonisys, Inc. | 2007-01-04 | 112 | 0 |
| K061392 | IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM | Ikonisys, Inc. | 2006-08-01 | 74 | 0 |
| K052577 | IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM | Ikonisys, Inc. | 2006-01-24 | 127 | 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