# K213670: BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Aug 25, 2023 after 641 days
- Product code: GIM (Tubes, Vacuum Sample, With Anticoagulant)
- 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: 1 generation back to K981013 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981013: Vacutainer Plus Tube with Edta Anticoagulant Andd Vacutainer Plus Serum Tube, Becton Dickinson Vacutainer Systems (1998) Summary page 5.

## Indications for use
BD Vacutainer® EDTA Blood Collection Tubes are evacuated, sterile, single use, in vitro diagnostic medical devices. They are intended to be used by trained healthcare professionals for the collection, containment, preservation, and transport of human venous blood specimens used for in vitro diagnostic testing. BD Vacutainer® K2EDTA and K3EDTA Blood Collection Tubes are used for testing in hematology including white blood cells (WBC), red blood cells (RBC), red blood cell distribution width (RDW), hemoglobin (HgB), hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), platelets, and 5-part white blood cell (WBC) differential counts (neutrophils, lymphocytes, monocytes, eosinophils, basophils).

Source page: https://510kreport.com/device/K213670
Methodology: https://510kreport.com/methodology