510(k) · Cleared
Recalled · Class II · 2014BD Vacutainer Trace Element Serum Plus Tube and BD Vacutainer Trace Element K2EDTA Plus Tube, Models 368380/368381
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson & CO · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on May 14, 2004 after an 18-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled once.
- Decided
- May 14, 2004
- Review
- 18 days
- Class
- Class II
- Product code
- JKA
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK041071 BD Vacutainer Trace Element Serum Plus Tube and BD Vacutainer Trace…Becton, Dickinson & CO · 2004
- Descendant · cites it directly · 0 of its ownK213953 BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace…Becton, Dickinson and Company · 2023
Most influential descendants
Showing 1 of 1 · See all- K213953BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum TubesBecton, Dickinson and Company · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041071 | BD Vacutainer Trace Element Serum Plus Tube and BD Vacutainer Trace Element… | Becton, Dickinson & CO | 2004 | — |
| +1 | K213953 | BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum… | Becton, Dickinson and Company | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JKA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JKA device
- #1 K200027 Blood Collection Needle with/without Holder…score 15.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | BD Vacutainer® Trace Element Serum Glass Tube Named without a submission number | |
| * | — | BD Vacutainer® Trace Element Na2 EDTA Glass Tube Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213953 | BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 23, 2014 | Class II | Z-2632-2014 | Storage | Products were held at improper storage temperature |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K213953 (Becton, Dickinson and Company, 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JKA devicesJKA Tubes, Vials, Systems, Serum Separators, Blood Collection: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JKA
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JKA
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JKA
13in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JKA
6,089in 2025
MAUDE reports naming product code JKA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 281 | 3 | 73 |
| 2008 | 2 | — | 3 | 78 |
| 2009 | 2 | — | 3 | 42 |
| 2010 | 4 | 28 | 4 | 37 |
| 2011 | 0 | — | 14 | 67 |
| 2012 | 1 | — | 2 | 54 |
| 2013 | 3 | 244 | 1 | 33 |
| 2014 | 1 | — | 1 | 68 |
| 2015 | 1 | — | 6 | 41 |
| 2016 | 4 | 116 | 1 | 65 |
| 2017 | 2 | — | 2 | 2,039 |
| 2018 | 1 | — | 2 | 9,731 |
| 2019 | 6 | 181 | 9 | 6,469 |
| 2020 | 6 | 181 | 0 | 3,774 |
| 2021 | 4 | 217 | 3 | 3,610 |
| 2022 | 9 | 164 | 2 | 3,375 |
| 2023 | 17 | 189 | 2 | 4,400 |
| 2024 | 6 | 240 | 0 | 4,609 |
| 2025 | 7 | 115 | 13 | 6,089 |
| 2026 | 8 | 250 | 1 | — |
What is it indicated for?
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.).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041071 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041071: BD Vacutainer Trace Element Serum Plus Tube and BD Vacutainer Trace Element K2EDTA Plus Tube, Models 368380/368381.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041071
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026