FDA Product Code KFM: Pump, Blood, Cardiopulmonary Bypass, Non-roller Type
Leading manufacturers include Qura S.R.L, Spectrum Medical S.R.L. and Cardiacassist, Inc..
FDA 510(k) Cleared Pump, Blood, Cardiopulmonary Bypass, Non-roller Type Devices (Product Code KFM)
About Product Code KFM - Regulatory Context
510(k) Submission Activity
84 total 510(k) submissions under product code KFM since 1977, with 84 receiving FDA clearance (average review time: 170 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 3 in the prior period.
FDA Review Time
Recent submissions under KFM have taken an average of 98 days to reach a decision - down from 172 days historically, suggesting improved FDA processing for this classification.
KFM devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →