FDA applicant
Burke Mobility Products
FDA records 4 decisions for Burke Mobility Products (Mission, KS) from 1990 to 1996: 4 510(k) clearances. Most are in product codes INI (Vehicle, Motorized 3-Wheeled) and FNL (Bed, Ac-Powered Adjustable Hospital). 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 Burke Mobility Products’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Burke Mobility Products since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Burke Mobility Products’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 “Burke”
FDA records each applicant name separately; these may or may not be the same firm.