# GIM: Tubes, Vacuum Sample, With Anticoagulant

- Device class: 2; regulation: 21 CFR 862.1675; FDA's rule: 510(k) required
- FDA decisions: 39
- 510(k) review time 2021–2025: median 277 days (middle half 268–459)
- Recalls: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1992: 7
- 1993: 1
- 1994: 3
- 1995: 2
- 1997: 2
- 2001: 1
- 2008: 1
- 2017: 1
- 2023: 2
- 2024: 1

## Most-cited predicates
- K896514: QS90 Smooth E Arterial Blood Sampler (1990), cited by 2
- K921636: Vacutainer (R) Brand Safety-Lok Blood Collect Set (1992), cited by 1
- K080552: Cyto-Chex BCT (2008), cited by 1
- K971221: Greiner Vacuette Blood Collection Tube (1997), cited by 1

Source page: https://510kreport.com/product-code/GIM
Data by year (CSV): https://510kreport.com/product-code/GIM.csv