FDA Product Code BZQ: Monitor, Breathing Frequency
Leading manufacturers include Linshom Medical, Inc., Respiree Pte, Ltd. and Hill-Rom, Inc..
FDA 510(k) Cleared Monitor, Breathing Frequency Devices (Product Code BZQ)
About Product Code BZQ - Regulatory Context
510(k) Submission Activity
174 total 510(k) submissions under product code BZQ since 1976, with 174 receiving FDA clearance (average review time: 155 days).
Submission volume has increased in recent years - 8 submissions in the last 24 months compared to 4 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under BZQ have taken an average of 236 days to reach a decision - up from 151 days historically. Manufacturers should account for longer review timelines in current project planning.
BZQ devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →