King Systems Corp. dba Ambu, Inc.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

the King LTS-D branded supraglottic airway with gastric access lumen is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g).

Passage 2

The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).

Passage 3

Statements on your website (https://www.ambuusa.com/airway-management-andanaesthesia/laryngeal-tubes/product/ambu-king-lts-d-disposable-laryngeal-tube) promote the device with an intended use for pediatric populations weighing less than 5 kg, 5-12kg, 12-25kg, and 25-35 kg. However, the cleared indication for use for your device is for adult patients (K033189.pdf (fda.gov); K033186.pdf (fda.gov); K021634.pdf (fda.gov), and not for pediatric sizes.