# K093910: Improvacuter Gel & Clot Activator Tube

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Improve Medical Instruments Co., Ltd.
- Decided: Jul 12, 2010 after 202 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 2.

## Indications for use
IMPROVACUTER Gel & Clot Activator Tube is a single use tube used to collect, transport, separate, and process venous blood specimens to obtain serum for clinical chemistry and immunology assays. It is used in settings where a venous blood sample is collected by a trained healthcare worker. For in vitro diagnostic use.

Source page: https://510kreport.com/device/K093910
Methodology: https://510kreport.com/methodology