# K240455: BD Vacutainer® Citrate Blood Collection Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Oct 31, 2024 after 259 days
- Product code: GIM (Tubes, Vacuum Sample, With Anticoagulant)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K013971 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013971: BD Vacutainer Safety Coagulation Tube, Becton, Dickinson & CO (2002) Summary page 6.

## Indications for use
The BD Vacutainer® Citrate Blood Collection Tube (0.109M buffered sodium citrate) is a sterile, single use tube used for the collection, containment, transport, and centrifugation of venous blood specimens to obtain plasma for in vitro diagnostic testing. It is used in settings where a venous blood sample is collected by a trained healthcare worker. The BD Vacutainer® Citrate Blood Collection Tube is used for clinical laboratory testing in coagulation.

Source page: https://510kreport.com/device/K240455
Methodology: https://510kreport.com/methodology