FDA product code GIM: Tubes, Vacuum Sample, With Anticoagulant
GIM is the FDA product code for tubes, vacuum sample, with anticoagulant. It is a Class II device, regulated under 21 CFR 862.1675 and reviewed by the Clinical Chemistry panel. FDA has cleared 39 510(k) submissions under GIM, 3 in the last five years, from 24 different applicants. The average 510(k) review took 91 days (median 57); 259 days on average over the last three years. FDA has posted 9 recalls for GIM devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Tubes, Vacuum Sample, With Anticoagulant |
| Device class | Class II |
| Regulation | 21 CFR 862.1675 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
510(k) clearances per year for GIM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 266 |
| 2023 | 2 | 459 |
| 2024 | 1 | 259 |
Compare with all 510(k) review times · Search every GIM clearance
Top GIM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sherwood Medical Industries | 5 | 1977-06-29 |
| Becton, Dickinson and Company | 3 | 2024-10-31 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 3 | 1995-02-06 |
| Sherwood Medical Co. | 3 | 1994-12-19 |
| Jelco Laboratories | 3 | 1977-12-02 |
19 more applicants have GIM clearances. See the full list in Caduvo.
Most recent GIM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240455 | Becton, Dickinson and Company | BD Vacutainer® Citrate Blood Collection Tubes | 2024-10-31 | 259 |
| K230493 | Becton, Dickinson and Company | BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube | 2023-11-27 | 277 |
| K213670 | Becton, Dickinson and Company | BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes | 2023-08-25 | 641 |
| K162723 | Caltag Medsystems, Ltd. | TransFix/EDTA Vacuum Blood Collection Tubes | 2017-06-22 | 266 |
| K080552 | Streck | CYTO-CHEX BCT | 2008-07-31 | 154 |
Recalls for GIM devices
9 product recalls in 9 recall events; 1 initiated in the last five years and 2 still open. Most recent: 2025-08-08.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2020 | 1 |
| 2021 | 2 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code GIM?
GIM is the FDA product code for tubes, vacuum sample, with anticoagulant. It is a Class II device, regulated under 21 CFR 862.1675 and reviewed by the Clinical Chemistry panel.
What device class is GIM?
Class II, regulation 21 CFR 862.1675. Typical premarket route: 510(k).
How long does a 510(k) take for product code GIM?
Across 39 cleared submissions the average was 91 days from receipt to decision (median 57).
Which companies have the most GIM clearances?
Sherwood Medical Industries (5); Becton, Dickinson and Company (3); Bd Becton Dickinson Vacutainer Systems Preanalytic (3); Sherwood Medical Co. (3); Jelco Laboratories (3).
Have GIM devices been recalled?
Yes: 9 product recalls across 9 recall events; the most recent began 2025-08-08.
Next steps
- Run an FDA pathway report with predicate devices for product code GIM
- Run a recall and safety report across every GIM manufacturer
- Watch product code GIM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Clinical Chemistry product codes · FDA product code lookup · 510(k) database search · 510(k) review times