FDA Product Code MNS: Ventilator, Continuous, Non-life-supporting
Leading manufacturers include Resmed Pty , Ltd., ResMed Corp and Compal Electronics, Inc..
FDA 510(k) Cleared Ventilator, Continuous, Non-life-supporting Devices (Product Code MNS)
About Product Code MNS - Regulatory Context
510(k) Submission Activity
47 total 510(k) submissions under product code MNS since 1996, with 47 receiving FDA clearance (average review time: 159 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under MNS have taken an average of 272 days to reach a decision - up from 149 days historically. Manufacturers should account for longer review timelines in current project planning.
MNS devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →