FDA: King Systems Promoted Oropharyngeal Airway for Off-Label Use

In a warning letter, the U.S. Food and Drug Administration (FDA) has ordered King Systems, a Consort Medical company, to stop marketing its King LT(S)-D orapharyngeal airway for off-label use.

The Office of Compliance in the Center for Devices and Radiological Healthreviewed www.kingsystems.com, for the King LT(S)-D oropharyngeal airway product and found that the device was being marketed as “intended for airway management in over four feet in height for controlled or spontaneous ventilation … for difficult and emergent airway cases … and (as) well-suited for ambulatory and office-based anesthesia.”

However, the FDA said the device was solely approved for use of “controlled ventilation during anesthesia” for short procedures in adults, when patients are considered at low risk of aspiration of stomach contents.

The agency gave the Noblesville, Ind.-based firm 15 days to respond in writing.

The King LTS-Dassists in the airway’s passage behind the larynx and into the normally collapsed esophagus.King Systems is adesigner and manufacturer of anesthesia and critical care products.

To view the complete warning letter, visit www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm191860.htm.