FDA-Device2024-11-06Class II
AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD420
King Systems Corp. dba Ambu, Inc.
Hazard
Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
Sold states
Nationwide
Affected count
N/A
Manufactured in
15011 Herriman Blvd, N/A, Noblesville, IN, United States
Products
AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD420
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0269-2025Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief