April 22nd, 2026
DEN250012 and 21 CFR 874.5400: What the FDA's 2026 Second-Line Classification Actually Changed
This authority article explains what FDA's March 4, 2026 De Novo decision actually changed for suction anti-choking devices. Written from Fitiger's engineering and product safety perspective, it breaks down DEN250012, 21 CFR 874.5400, special controls, pressure verification, one-way valve safety logic, human factors, and the procurement implications for schools, care settings, and risk teams.
