# K023331: BD Vacutainer SST II Plus Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Nov 25, 2002 after 52 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 K960250 (1996). 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)
- K960250: Vacutainer Brand Plus Serum & SST Tubes, Becton Dickinson Vacutainer Systems (1996) Summary page 3.
- (no number) BD Vacutainer Brand Serum Tube: named in the summary without a submission number

## Indications for use
The BD VacutainerTM SSTTMII PLUS Tube is a plastic evacuated blood collection tube with silica clot activator and gel barrier material that provides a means of collecting, transporting, separating, and processing blood in a closed tube. Blood collected in a BD VacutainerTM SSTTM II PLUS Tube is primarily used for clinical laboratory testing - chemistry assays using patient serum but may be used for other assays requiring serum specimens as determined by the laboratory. In addition, the BD VacutainerTM SSTTM11 PLUS Tube is compatible with many commonly used therapeutic drugs and is therefore suitable for therapeutic drug monitoring (TDM).

Source page: https://510kreport.com/device/K023331
Methodology: https://510kreport.com/methodology