# K213953: BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Jul 17, 2023 after 577 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: 1 generation back to K041071 (2004). 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)
- K041071: BD Vacutainer Trace Element Serum Plus Tube and BD Vacutainer Trace Element K2EDTA Plus Tube, Models 368380/368381, Becton, Dickinson & CO (2004) Summary page 5.

## Indications for use
BD Vacutainer® Trace Element Serum Tubes and BD Vacutainer® Trace Element K2EDTA Tubes are plastic, evacuated, sterile, single use, in vitro diagnostic medical devices. They are intended to be used in settings where venous blood specimens are collected by trained healthcare professionals for the collection, transportation, and processing of blood in a closed tube. Blood collected in the BD Vacutainer® Trace Element Serum Tubes and BD Vacutainer® Trace Element K2EDTA Tubes are used for trace element testing (e.g., Arsenic, Cadmium, Chromium, Copper, Lead, Manganese, Mercury, Selenium, and Zinc).

Source page: https://510kreport.com/device/K213953
Methodology: https://510kreport.com/methodology