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King Systems Corp. dba Ambu, Inc. was cited for manufacturing the King LTS-D supraglottic airway without required regulatory approval, violating the Federal Food, Drug, and Cosmetic Act. The company failed to submit a premarket approval (PMA) application or investigational device exemption (IDE) before commercializing the device, rendering it adulterated, and did not provide the required section 510(k) notification to FDA prior to market introduction, making it misbranded. The violations were identified during an FDA inspection conducted May 15-16, 2023 at the firm's Noblesville, Indiana facility.