# K041071: BD Vacutainer Trace Element Serum Plus Tube and BD Vacutainer Trace Element K2EDTA Plus Tube, Models 368380/368381

- Pathway: 510(k) (Special)
- Applicant: Becton, Dickinson & CO
- Decided: May 14, 2004 after 18 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) BD Vacutainer® Trace Element Serum Glass Tube: named in the summary without a submission number
- (no number) BD Vacutainer® Trace Element Na2 EDTA Glass Tube: named in the summary without a submission number

## Most influential descendants
- K213953: BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes (2023), 0 descendants of its own

## Recalls of this device
- Jun 23, 2014 · Class II · Z-2632-2014: Products were held at improper storage temperature

## Indications for use
The BD Vacutainer® Trace Element Serum Plus Tube and the BD Vacutainer® Trace Element K 2EDTA Plus Tube are plastic evacuated blood collection tubes that provide a means of collecting, transporting, and processing blood in a closed tube. Blood collected in the BD Vacutainer® Trace Element Serum Plus Tube and BD Vacutainer® Trace Element K 2 EDTA Plus Tube is used for trace element testing (e.g., Arsenic, Cadmium, Calcium, Chromium, Copper, Iron, Lead, Magnesium, Manganese, Mercury, Selenium, and Zinc.).

Source page: https://510kreport.com/device/K041071
Methodology: https://510kreport.com/methodology