# K230855: BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Dec 20, 2023 after 267 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: 2 generations back to K960250 (1996). 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)
- K023075: BD Vacutainer Plus SST Serum Separator Tube, Bd Vacutainer Systems Preanalyical Solutions (2002) Summary page 5.

## Indications for use
The BD Vacutainer® Serum Separator (SST™) Blood Collection Tube is a sterile, single use tube used for the collection, containment, transport, and centrifugation of venous blood specimens to obtain and store serum for in vitro diagnostic testing. It is used in settings where a venous blood specimen is collected by a trained healthcare professional. The BD Vacutainer® Serum Separator (SST™) Blood Collection Tube is used for clinical laboratory testing in chemistry and for the monitoring of certain therapeutic drugs.

Source page: https://510kreport.com/device/K230855
Methodology: https://510kreport.com/methodology