DeviceClearance

Product code PMB— Anesthesiology

cNEP Airway

Classification name
External Airway
Device class
Class 2
Regulation
21 CFR 868.5105
Advisory panel
Anesthesiology
Total cleared
1
First cleared
Most recent

FDA classification definition

“This device is intended to maintain airway patency using negative pressure during mild to moderate sedation.”

— U.S. Food and Drug Administration, device classification record for product code PMB under 21 CFR 868.5105, via openFDA

Market context for product code PMB

FDA has cleared 1 device under product code PMB, all in 2015, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code PMB

Recent clearances under product code PMB

Data sourced from openFDA. This site is unofficial and independent of the FDA.