# K011699: Vacuette Evacuated Blood Collection Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Greiner Bio-One Vacuette North America
- Decided: Jun 28, 2001 after 27 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 K944566 (1994). 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)
- K960857: Greiner Vacuette Blood Collection Tube W/Lithium Heparin & Gel Separator, Greiner America, Inc. (1996) Summary page 1.

## Indications for use
VACUETTE® tubes with sodium heparin are used to collect, transport and process blood for testing plasma or whole blood in the clinical laboratory.

Source page: https://510kreport.com/device/K011699
Methodology: https://510kreport.com/methodology