FDA Product Code BYI: Percussor, Powered-electric
Leading manufacturers include Electromed, Inc., Baxter Healthcare Corportation and Chongqing Moffy Innovation Technology Co., Ltd..
FDA 510(k) Cleared Percussor, Powered-electric Devices (Product Code BYI)
About Product Code BYI - Regulatory Context
510(k) Submission Activity
58 total 510(k) submissions under product code BYI since 1977, with 58 receiving FDA clearance (average review time: 120 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under BYI have taken an average of 210 days to reach a decision - up from 113 days historically. Manufacturers should account for longer review timelines in current project planning.
BYI devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →