FDA Product Code CAC: Apparatus, Autotransfusion
Recovering the patient's own shed blood reduces transfusion requirements during surgery. FDA product code CAC covers autotransfusion apparatus used in operative and post-operative blood recovery.
These systems collect, filter, wash, and reinfuse the patient's own shed blood during cardiac, vascular, and orthopedic surgery. Autotransfusion reduces allogeneic blood exposure and its associated risks, including transfusion reactions and infection transmission.
CAC devices are Class II medical devices, regulated under 21 CFR 868.5830 and reviewed by the FDA Hematology panel.
Leading manufacturers include Inari Medical, Inc., Sorin Group Italia S.R.L. and Inari Medical.
FDA 510(k) Cleared Apparatus, Autotransfusion Devices (Product Code CAC)
About Product Code CAC - Regulatory Context
510(k) Submission Activity
195 total 510(k) submissions under product code CAC since 1977, with 195 receiving FDA clearance (average review time: 153 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 5 in the prior period.
FDA Review Time
Recent submissions under CAC have taken an average of 99 days to reach a decision - down from 154 days historically, suggesting improved FDA processing for this classification.
CAC devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →