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 Sherwood Medical Industries, Becton, Dickinson and Company and Sherwood Medical Co..
39
Total
39
Cleared
91d
Avg days
1976
Since
Declining activity -
1 submissions in the last 2 years
vs 2 in the prior period
Review times increasing: avg
259d
recently vs 86d historically
FDA 510(k) Cleared Tubes, Vacuum Sample, With Anticoagulant Devices (Product Code GIM)
39 devices
Cleared
Oct 31, 2024
BD Vacutainer® Citrate Blood Collection Tubes
Becton, Dickinson and Company
Hematology
259d
Cleared
Nov 27, 2023
BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube
Becton, Dickinson and Company
Hematology
277d
Cleared
Aug 25, 2023
BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes
Becton, Dickinson and Company
Hematology
641d
Cleared
Feb 06, 1995
VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry
91d
Cleared
Dec 19, 1994
CORVAC PLASTIC BLOOD COLLECTION TUBE
Sherwood Medical Co.
Chemistry
81d
Cleared
May 02, 1994
MONOJECT BLOOD COLLECTION TUBES W/SAFETY STOPPER
Sherwood Medical Co.
Chemistry
117d
Cleared
Feb 07, 1994
BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT
Organon Teknika Corp.
Microbiology
179d
Cleared
Oct 12, 1993
VACUTAINER BRAND SAFETY-GARD NEEDLE HOLDER & NEEDLE DISPOSABLE CONTAINER SYSTEM
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry
92d
Cleared
May 28, 1992
DIRECTDRAW SUPERSERUM
International Technidyne Corp.
Chemistry
44d
Cleared
Apr 29, 1992
VACUTAINER(R) BRAND SAFETY-LOK BLOOD COLLECT SET
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry
23d
Cleared
Jan 08, 1992
VACUTAINER KIT
Abbott Laboratories
Chemistry
68d
Cleared
Jan 08, 1992
CORVAC BLOOD COLLECTION TUBE
Sherwood Medical Co.
Chemistry
51d
Cleared
Jan 23, 1990
QS90 SMOOTH E ARTERIAL BLOOD SAMPLER
Radiometer America, Inc.
Chemistry
70d
Cleared
Jul 18, 1988
ACCUFIBRIN(TM) BLOOD COLLECTION SYSTEM AF100
Terumo Medical Corp.
Hematology
31d
Cleared
Aug 04, 1977
LIQUAEMIB SODIUM PRESERVATIVE, ETC.
Organon, Inc.
Hematology
21d
Cleared
Aug 04, 1977
LIQUAEMIN SODIUM, HEPARIN SODIUM ETC.
Organon, Inc.
Hematology
21d
Cleared
Jun 29, 1977
BLOOD COLLECTION TUBE, GRAY
Sherwood Medical Industries
Chemistry
16d
Cleared
Jun 29, 1977
BLOOD COLLECTION TUBE, BLUE
Sherwood Medical Industries
Chemistry
16d
Cleared
Jun 29, 1977
BLOOD COLLECTION TUBE, RED
Sherwood Medical Industries
Chemistry
16d
Cleared
Jun 29, 1977
BLOOD COLLECTION TUBE, GREEN
Sherwood Medical Industries
Chemistry
16d
Cleared
Jun 27, 1977
BLOOD COLLECTION TUBE, LAVENDER
Sherwood Medical Industries
Chemistry
14d
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 510(k) Review Time - GIM Product Code
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 Chemistry panel. Browse all Chemistry devices →