FDA Product Code GIM: Tubes, Vacuum Sample, With Anticoagulant
FDA product code GIM covers vacuum sample tubes containing anticoagulants used for hematology testing.
These evacuated tubes contain EDTA, heparin, or sodium citrate anticoagulants that prevent blood clotting during collection and transport, preserving cell morphology and enabling accurate complete blood counts, coagulation studies, and blood film preparation.
GIM devices are Class II medical devices, regulated under 21 CFR 862.1675 and reviewed by the FDA Hematology panel.
Leading manufacturers include Becton, Dickinson and Company.
FDA 510(k) Cleared Tubes, Vacuum Sample, With Anticoagulant Devices (Product Code GIM)
About Product Code GIM - Regulatory Context
510(k) Submission Activity
39 total 510(k) submissions under product code GIM since 1976, with 39 receiving FDA clearance (average review time: 91 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA Review Time
Recent submissions under GIM have taken an average of 259 days to reach a decision - up from 86 days historically. Manufacturers should account for longer review timelines in current project planning.
GIM devices are reviewed by the Hematology panel. Browse all Hematology devices →