FDA Product Code BZD: Ventilator, Non-continuous (respirator)
FDA product code BZD covers non-continuous ventilators, also known as intermittent positive pressure breathing (IPPB) devices and home respiratory support equipment.
Unlike continuous ventilators, these devices deliver assisted breaths only when triggered by the patient or on an intermittent schedule. They are used for the treatment of chronic respiratory conditions, post-operative respiratory therapy, and as backup support for patients with mild ventilatory insufficiency.
BZD devices are Class II medical devices, regulated under 21 CFR 868.5905 and reviewed by the FDA Anesthesiology panel.
Leading manufacturers include Respironics, Inc., Sleepnet Corporation and ResMed Corp.
FDA 510(k) Cleared Ventilator, Non-continuous (respirator) Devices (Product Code BZD)
About Product Code BZD - Regulatory Context
510(k) Submission Activity
460 total 510(k) submissions under product code BZD since 1977, with 460 receiving FDA clearance (average review time: 155 days).
Submission volume has increased in recent years - 23 submissions in the last 24 months compared to 6 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - BZD Product Code
Recent submissions under BZD have taken an average of 184 days to reach a decision - up from 153 days historically. Manufacturers should account for longer review timelines in current project planning.
BZD devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →