FDA applicant
Mui Scientific
FDA records 5 decisions for Mui Scientific (Mississauga, CA) from 1983 to 2026: 5 510(k) clearances. All are in product code FFX (System, Gastrointestinal Motility (Electrical)). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Mui Scientific, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Mui Scientific’s devices, and how often a recall has named them.
FDA decisions per year
1in 2017
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Mui Scientific’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