FDA Product Code CAF: Nebulizer (direct Patient Interface)
Nebulizers convert liquid medication into an inhalable aerosol. FDA product code CAF covers nebulizers with direct patient interface used for respiratory drug delivery.
These devices use compressed air, ultrasonic vibration, or vibrating mesh technology to aerosolize bronchodilators, corticosteroids, and other respiratory medications into particles small enough to reach the lower airways. They are used in the treatment of asthma, COPD, and cystic fibrosis.
CAF devices are Class II medical devices, regulated under 21 CFR 868.5630 and reviewed by the FDA Anesthesiology panel.
Leading manufacturers include Pari Respiratory Equipment, Inc., Medline Industries, LP and Thayer Medical Corporation.
FDA 510(k) Cleared Nebulizer (direct Patient Interface) Devices (Product Code CAF)
About Product Code CAF - Regulatory Context
510(k) Submission Activity
507 total 510(k) submissions under product code CAF since 1976, with 507 receiving FDA clearance (average review time: 158 days).
Submission volume has declined in recent years - 8 submissions in the last 24 months compared to 14 in the prior period.
FDA Review Time
Recent submissions under CAF have taken an average of 207 days to reach a decision - up from 158 days historically. Manufacturers should account for longer review timelines in current project planning.
CAF devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →