FDA applicant
Dept. of the Army
FDA records 5 decisions for Dept. of the Army (Falls Church, VA) from 1989 to 2003: 5 510(k) clearances. Most are in product codes MAC (Decontamination Kit) and IZL (System, X-Ray, Mobile). Its devices cite 1 predicate, 1 of them its own earlier devices. 1 recall is linked to its devices, 1 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Dept. of the Army’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Dept. of the Army since 2007.
Recalls per year
1in 2022
Class I Class II/III not classified
Planning a device like Dept. of the Army’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 “Dept.”
FDA records each applicant name separately; these may or may not be the same firm.