510(k) · Cleared
ClearedBD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Jul 17, 2023 as substantially equivalent to K041071 (Becton, Dickinson & CO, 2004) after a 577-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Jul 17, 2023
- Review
- 577 days
- Class
- Class II
- Product code
- JKA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K041071 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK041071 BD Vacutainer Trace Element Serum Plus Tube and BD Vacutainer Trace…Becton, Dickinson & CO · 2004 · Recalled
- This deviceK213953 BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace…Becton, Dickinson and Company · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K041071 | BD Vacutainer Trace Element Serum Plus Tube and BD Vacutainer Trace Element… | Becton, Dickinson & CO | 2004 | 1 |
| 0 (this device) | K213953 | BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum… | Becton, Dickinson and Company | 2023 | — |
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? (1)
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 |
|---|---|---|---|
| * | K041071 | BD Vacutainer Trace Element Serum Plus Tube and BD Vacutainer Trace Element K2EDTA Plus…Summary page 5…5 Regulatory Class: Class II Product Code: JKA 1.9 Predicate Device BD Vacutainer® Trace Element Serum Plus Tube and BD Vacutainer® Trace Element K 2EDTA Plus Tube (K041071) 1.10 Device Establishment Becton, Dickinson and Company 1.11 Registration Number: 2243072 1.12 Performance Standards:… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
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. 2023, this device’s year, is highlighted.
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?
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).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213953 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213953: BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213953
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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