Steven Block
President & CEO
King Systems Corp. dba Ambu, Inc.
6721 Columbia Gateway Drive, Suite 200
Columbia , MD 21046
United StatesFEI 1824226Issued Aug 16, 2023Center for Devices and Radiological Health
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 1824226.
Violations1
Issue DateAug 16, 2023
Product TypeMedical Devices
StatusClosed
Closeout LetterJun 16, 2025
Letter Details
Firm
King Systems Corp. dba Ambu, Inc.
Location
Steven Block
President & CEO
King Systems Corp. dba Ambu, Inc.
6721 Columbia Gateway Drive, Suite 200
Columbia , MD 21046
United States
FEI Number
1824226
Country
United States
Issue Date
August 16, 2023
Issuing Office
Center for Devices and Radiological Health
Product Type
Medical Devices
Status
Closed
Closeout Letter
June 16, 2025
Summary
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.
King Systems Corp. dba Ambu, Inc. FDA Warning Letter, August 16, 2023
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