# K182078: MiniCollect K2E K2EDTA Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Greiner Bio-One Na, Inc.
- Decided: Jan 25, 2019 after 176 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 K940905 (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)
- K093972: BD Microtainer Map Microtube for Automated Process, Model 363706, Becton, Dickinson & CO (2010) Summary page 4.

## Indications for use
MiniCollect® K2E K2EDTA Tubes are non-evacuated blood collection devices, used to collect, transport, store, and evaluate capillary blood specimens for the following hematology parameters: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, Platelets, RDW, Lymphocytes, Neutrophils, Monocytes, Eosinophils and Basophils.

Source page: https://510kreport.com/device/K182078
Methodology: https://510kreport.com/methodology