FDA Product Code BZE: Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer
Leading manufacturers include Medline Industries, LP, Exceleron Medical and Guangdong Eda Technology Co., Ltd..
FDA 510(k) Cleared Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer Devices (Product Code BZE)
About Product Code BZE - Regulatory Context
510(k) Submission Activity
45 total 510(k) submissions under product code BZE since 1976, with 45 receiving FDA clearance (average review time: 189 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for BZE submissions have been consistent, averaging 180 days recently vs 190 days historically.
BZE devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →