# K921806: Vacutainer (R) Brand SST (R) and Cat Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Apr 29, 1992 after 14 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K960858: Greiner Vacutte Blood Collection Tube W/ Clot Activator & Gel Separator (1996), 1 descendant of its own
- K983952: Greiner Vacuette Blood Collection Tube (1998), 0 descendants of its own

## Recalls of this device
- Jun 23, 2014 · Class II · Z-2630-2014: 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

Source page: https://510kreport.com/device/K921806
Methodology: https://510kreport.com/methodology