# K252040: BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Mar 13, 2026 after 256 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- 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 K944566 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945952: Vacutainer (R) Brand Plus PST (TM) Plasma Separation Tube, Bd Becton Dickinson Vacutainer Systems Preanalytic (1995) Summary page 7.
- K944566: Vacutainer Brand Plus Sodium Heparin Tube, Bd Becton Dickinson Vacutainer Systems Preanalytic (1994) Summary page 7.

## Indications for use
The BD Vacutainer® Plasma Separator Tubes (PST™) are evacuated, sterile, single-use, in vitro diagnostic medical devices. They are intended to be used by healthcare professionals for the collection, containment, and transport of human venous blood specimens, and the subsequent separation and storage of plasma for in vitro diagnostic testing. BD Vacutainer® Plasma Separator Tubes (PST™) are used for testing chemistry analytes in plasma samples. The BD Vacutainer® Sodium Heparin Blood Collection Tube is a sterile, single-use, in vitro diagnostic medical device for the collection, containment, transport of human venous blood specimens, and the subsequent separation of plasma by centrifugation, for in vitro diagnostic testing. It is used in settings where a venous blood specimen is collected by a healthcare professional. The BD Vacutainer® Sodium Heparin Blood Collection Tube is used for testing lithium.

Source page: https://510kreport.com/device/K252040
Methodology: https://510kreport.com/methodology