FDA Product Code FIB: Protector, Transducer, Dialysis
Leading manufacturers include Bain Medical Equipment (Guangzhou) Co., Ltd..
FDA 510(k) Cleared Protector, Transducer, Dialysis Devices (Product Code FIB)
About Product Code FIB - Regulatory Context
510(k) Submission Activity
35 total 510(k) submissions under product code FIB since 1981, with 35 receiving FDA clearance (average review time: 102 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under FIB have taken an average of 158 days to reach a decision - up from 100 days historically. Manufacturers should account for longer review timelines in current project planning.
FIB devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →