FDA applicant
The Monarch Company
FDA records 1 decision for The Monarch Company (Birmingham, AL) in 2023: 1 510(k) clearance. All are in product code JKA (Tubes, Vials, Systems, Serum Separators, Blood…). 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 The Monarch Company’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like The Monarch Company’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 “The”
FDA records each applicant name separately; these may or may not be the same firm.