Device product
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
Z-0269-2025
Product summary
- Event
- Event 95451
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-0269-2025
Official wording
Reason: 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.
Code information: UDI-DI: 00612649210131 (Shipper Label); 00612649210148 (Piece Label)
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
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.