FDA applicant
Ars Enterprises, Inc.
FDA records 4 decisions for Ars Enterprises, Inc. (Santa Fe Springs, CA) from 1984 to 1985: 4 510(k) clearances. Most are in product codes FLE (Sterilizer, Steam) and FLF (Sterilizer, Ethylene-Oxide Gas). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ars Enterprises, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Ars Enterprises, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Ars Enterprises, 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