FDA Product Code JKA: Tubes, Vials, Systems, Serum Separators, Blood Collection
Under FDA product code JKA, blood collection tubes, vials, and serum separator systems are cleared for the collection and processing of clinical specimens.
These devices include evacuated tubes with various additives — anticoagulants, gels, clot activators — that preserve specimen integrity for specific laboratory tests. Serum separators use a gel barrier to separate serum from clot after centrifugation, simplifying sample processing.
JKA devices are Class II medical devices, regulated under 21 CFR 862.1675 and reviewed by the FDA Chemistry panel.
Leading manufacturers include Becton, Dickinson and Company, Jiangsu Caina Medical Co.,Ltd and Becton Dickinson Infusion Therapy Systems, Inc..
FDA 510(k) Cleared Tubes, Vials, Systems, Serum Separators, Blood Collection Devices (Product Code JKA)
About Product Code JKA - Regulatory Context
510(k) Submission Activity
236 total 510(k) submissions under product code JKA since 1977, with 236 receiving FDA clearance (average review time: 144 days).
Submission volume has declined in recent years - 13 submissions in the last 24 months compared to 29 in the prior period.
FDA Review Time
Recent submissions under JKA have taken an average of 166 days to reach a decision - up from 142 days historically. Manufacturers should account for longer review timelines in current project planning.
JKA devices are reviewed by the General Hospital panel. Browse all General Hospital devices →