FDA applicant
Avi, Inc.
FDA records 13 decisions for Avi, Inc. (St. Paul, MN) from 1981 to 1988: 13 510(k) clearances. All are in product code FRN (Pump, Infusion). 32 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Avi, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Avi, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Avi, 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) Report