# K960250: Vacutainer Brand Plus Serum & SST Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Vacutainer Systems
- Decided: Mar 29, 1996 after 73 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) VACUTAINER® Brand PLUS Serum and SST® Serum Separator Tubes (All Tube Volumes): named in the summary without a submission number

## Most influential descendants
- K023075: BD Vacutainer Plus SST Serum Separator Tube (2002), 3 descendants of its own
- 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
- K023331: BD Vacutainer SST II Plus Tubes (2002), 0 descendants of its own

## Recalls of this device
- Jun 23, 2014 · Class II · Z-2629-2014: Products were held at improper storage temperature
- Jun 23, 2014 · Class II · Z-2631-2014: Products were held at improper storage temperature
- 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
An evacuated tube which provides a means of collecting, transporting, separating and processing venous blood in a closed system. Blood collected in these tubes is primarily used for clinical laboratory chemistry assays using patient serum but may be used for other serum specimens as determined by the laboratory.

Source page: https://510kreport.com/device/K960250
Methodology: https://510kreport.com/methodology