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FDA Warning Letter Explorer
Medical Devices · Aug 16, 2023

King Systems Corp. dba Ambu, Inc.

3 extracted findings

FDA source excerpt, selected passage

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).

FDA published a close-out letter on Jun 16, 2025. The findings below are from the original warning letter.

Findings and supporting evidence

Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.

Findings extracted from the letter

Selected FDA passages, not the complete letter.

01
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).
02
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).
03
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.

Sections and clauses cited

As cited in this historical letter, not a statement of current regulatory requirements.

21 CFR 807.81(b)

For background, see Premarket notification (510(k)). Explore Botable’s work in Medical devices and Quality and regulatory operations.

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