# K971236: Greiner Vacuette Blood Collection Tube

- Pathway: 510(k) (Traditional)
- Applicant: Greiner America, Inc.
- Decided: May 12, 1997 after 40 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Becton Dickinson's Vacutainer® brand EDTA K, additive tube: named in the summary without a submission number

## Recalls of this device
- Aug 13, 2021 · Class II · Z-2485-2021: Blood collection tubes may experience a clotting issue.
- Aug 12, 2011 · Not classified · Z-0184-2012: Vacuette 4ml EDTA DK2 tubes have been reported for short fills to no fills.

## Indications for use
The Greiner Vacuette® blood collection tube with EDTA K, is an evacuated blood collection device containing EDTA K, anticoagulant additive and intended for use in evaluations of whole blood specimens.

Source page: https://510kreport.com/device/K971236
Methodology: https://510kreport.com/methodology