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Uscom Kft, a Hungarian manufacturer of spirometer devices, was cited for marketing the SpiroSonic AIR without required FDA premarket approval (PMA) or investigational device exemption, and for failing to submit a 510(k) notification prior to commercial distribution. The spirometer was determined to be adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act because the company lacked the necessary regulatory clearance for this particular device model, despite holding prior clearance for a different spirometer product dated May 2015. The violations were identified during an FDA inspection conducted January 27-30, 2025, at the company's Budapest manufacturing facility.