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 Sleepnet Corporation, ResMed Corp and Respironics, Inc..
FDA 510(k) Cleared Ventilator, Non-continuous (respirator) Devices (Product Code BZD)
About Product Code BZD - Regulatory Context
510(k) Submission Activity
457 total 510(k) submissions under product code BZD since 1977, with 457 receiving FDA clearance (average review time: 154 days).
Submission volume has increased in recent years - 21 submissions in the last 24 months compared to 5 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for BZD submissions have been consistent, averaging 170 days recently vs 154 days historically.
BZD devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →