FDA Product Code MNT: Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
Leading manufacturers include Maquet Critical Care AB, Fisher &Paykel Healthcare , Ltd. and Breas Medical AB.
FDA 510(k) Cleared Ventilator, Continuous, Minimal Ventilatory Support, Facility Use Devices (Product Code MNT)
About Product Code MNT - Regulatory Context
510(k) Submission Activity
25 total 510(k) submissions under product code MNT since 1996, with 25 receiving FDA clearance (average review time: 223 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 MNT have taken an average of 260 days to reach a decision - up from 215 days historically. Manufacturers should account for longer review timelines in current project planning.
MNT devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →