Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Iris International, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K093861 | IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA C | Iris International, Inc. | 2010-02-05 | 51 | 4 |
| K060280 | ICHEM 100 URINE CHEMISTRY ANALYZER | Iris International, Inc. | 2006-06-13 | 131 | 0 |
| K050235 | IQ 200 URINE ANALYZER BODY FLUIDS MODULE | Iris International, Inc. | 2005-03-23 | 50 | 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