# K960860: Greiner Vacuette Blood Collection Tube E/Edta K3

- Pathway: 510(k) (Traditional)
- Applicant: Greiner America, Inc.
- Decided: Sep 5, 1996 after 188 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K940905 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940905: Microtainer Brand Tube with Edta (K2), Bd Becton Dickinson Vacutainer Systems Preanalytic (1994) Summary page 1.

## Recalls of this device
- Mar 31, 2023 · Class II · Z-1583-2023: Some of the tubes may be incorrectly labeled.

## Indications for use
The Greiner Vacuette™ blood collection tube with EDTA K3 is an evacuated blood collection device containing EDTA K3 anticoagulant additive and intended for use in evaluations of whole blood specimens.

Source page: https://510kreport.com/device/K960860
Methodology: https://510kreport.com/methodology