# K960858: Greiner Vacutte Blood Collection Tube W/ Clot Activator & Gel Separator

- Pathway: 510(k) (Traditional)
- Applicant: Greiner America, Inc.
- Decided: Aug 30, 1996 after 182 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
Longest line of descent: 1 generation back to K921806 (1992). 1 ancestor in all.
1 later device descends 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)
- K921806: Vacutainer (R) Brand SST (R) and Cat Tubes, Bd Becton Dickinson Vacutainer Systems Preanalytic (1992) Summary page 1.

## Most influential descendants
- K983952: Greiner Vacuette Blood Collection Tube (1998), 0 descendants of its own

## Recalls of this device
- May 14, 2024 · Class II · Z-2375-2024: The firm received reports that some blood collection tubes have experienced issues with clotting and poor separation due to missing additive. The failure of the device would likely require sample reco
- Jul 28, 2005 · Not classified · Z-0086-06: Serum Blood Collection tubes found with excess of Blood Clot Accelerator (BCA) solution.

## Indications for use
The product is intended for use in holding and separating blood serum from the cellular components of blood.

Source page: https://510kreport.com/device/K960858
Methodology: https://510kreport.com/methodology