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 Fisher &Paykel Healthcare , Ltd., Shenzhen Mindray Bio-Medical Electronics Co., Ltd. and Sleepnet Corporation.