FDA applicant
Iris International, Inc.
FDA records 3 decisions for Iris International, Inc. (Chatsworth, CA) from 2005 to 2010: 3 510(k) clearances. Most are in product codes JIL (Method, Enzymatic, Glucose (Urinary…) and LKM (Counter, Urine Particle). Its devices cite 5 predicates, 0 of them its own earlier devices. 5 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Iris International, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2010
2026 so far, outlined.
Recalls per year
4in 2023
Class I Class II/III not classified
Planning a device like Iris International, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Iris”
FDA records each applicant name separately; these may or may not be the same firm.