FDA applicant
Mgc Diagnostics Corporation
FDA records 1 decision for Mgc Diagnostics Corporation (St. Paul, MN) in 2025: 1 510(k) clearance. All are in product code MXA (System, Test, Breath Nitric Oxide). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Mgc Diagnostics Corporation’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
Planning a device like Mgc Diagnostics Corporation’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