FDA WARNING_LETTER - King Systems Corp. dba Ambu, Inc. - May 16, 2023

An FDA inspection of King Systems Corp., dba Ambu, Inc., from May 15-16, 2023, identified significant violations regarding their King LTS-D branded supraglottic airway with gastric access lumen. The device was found to be adulterated under section 501(f)(1)(B) of the Act because the firm lacks an approved premarket approval (PMA) or investigational device exemption (IDE) application. Additionally, the device is misbranded under section 502(o) and 510(k) of the Act, as the firm failed to notify the agency of its intent to introduce the device into commercial distribution. A critical compliance issue noted was the promotion of the device on the firm's website for pediatric populations (less than 5 kg, 5-12kg, 12-25kg, and 25-35 kg), which is an uncleared indication, as the device's cleared use is for adult patients. The FDA requires the firm to promptly address these violations, remove the unsupported pediatric claims from its website, or submit a 510(k) for the proposed indication. The firm must provide a written response within fifteen business days detailing specific corrective actions, including documentation and a timetable for systemic changes. Failure to comply may lead to severe regulatory actions, including seizure, injunction, civil money penalties, and impact on federal contracts.