# K023075: BD Vacutainer Plus SST Serum Separator Tube

- Pathway: 510(k) (Traditional)
- Applicant: Bd Vacutainer Systems Preanalyical Solutions
- Decided: Nov 25, 2002 after 70 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K960250 (1996). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960250: Vacutainer Brand Plus Serum & SST Tubes, Becton Dickinson Vacutainer Systems (1996) Summary page 3.

## Most influential descendants
- K230855: BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes (2023), 0 descendants of its own
- K093910: Improvacuter Gel & Clot Activator Tube (2010), 0 descendants of its own
- K060364: Vacu Lab Plain Tube, Vacu Lab Gel & Clot Activator Tube, Vacu Lab Coagulation Tube (2006), 0 descendants of its own

## Recalls of this device
- Feb 13, 2018 · Class II · Z-2056-2018: Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube
- Feb 13, 2018 · Class II · Z-2055-2018: Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube
- Aug 20, 2004 · Not classified · Z-0052-05: "Please be aware tht this not a new recall. The firm has taken action; but, due to administrative issues additional products are now being classified by the agency". There is an apparent bias in the d

## Indications for use
The Vacutainer PLUS SST Tube is a plastic evacuated blood collection tube with silica clot activator and gel that provides a means of collecting, transporting, separating, and processing blood in a closed tube. Blood collected in a Vacutainer PLUS SST Tube is primarily used for clinical laboratory testing in chemistry using patient serum, but may be used for other assays requiring serum specimens as determined by the laboratory. In addition, the Vacutainer PLUS SST Tube is compatible with many commonly used therapeutic drugs therefore suitable for therapeutic drug monitoring (TDM). Blood can be collected, processed and stored in a Vacutainer PLUS SST tube for at least 24 hours for therapeutic drug monitoring without large losses in recovery.

Source page: https://510kreport.com/device/K023075
Methodology: https://510kreport.com/methodology