FDA Product Code CBK: Ventilator, Continuous, Facility Use
Under FDA product code CBK, continuous facility-use ventilators are cleared for the life support of patients with acute or chronic respiratory failure in hospital settings.
These devices provide full or partial ventilatory support through a range of modes — including volume control, pressure control, and synchronized intermittent mandatory ventilation — in intensive care units and step-down wards. They are among the most critical devices in hospital infrastructure.
CBK devices are Class II medical devices, regulated under 21 CFR 868.5895 and reviewed by the FDA Anesthesiology panel.
Leading manufacturers include Sleepnet Corporation, Fisher &Paykel Healthcare , Ltd. and Shenzhen Mindray Bio-Medical Electronics Co., Ltd..
FDA 510(k) Cleared Ventilator, Continuous, Facility Use Devices (Product Code CBK)
About Product Code CBK - Regulatory Context
510(k) Submission Activity
504 total 510(k) submissions under product code CBK since 1976, with 504 receiving FDA clearance (average review time: 175 days).
Submission volume has increased in recent years - 14 submissions in the last 24 months compared to 6 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under CBK have taken an average of 268 days to reach a decision - up from 173 days historically. Manufacturers should account for longer review timelines in current project planning.
CBK devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →