510(k) · Cleared
Recalled · Class II · 2018BD Vacutainer Safety Coagulation Tube
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 Feb 1, 2002 after a 60-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled 5 times.
- Decided
- Feb 1, 2002
- Review
- 60 days
- Class
- Class II
- Product code
- JKA
- Recalls
- 5
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK013971 BD Vacutainer Safety Coagulation TubeBecton, Dickinson & CO · 2002
- Descendant · cites it directly · 0 of its ownK240455 BD Vacutainer® Citrate Blood Collection TubesBecton, Dickinson and Company · 2024
Most influential descendants
Showing 1 of 1 · See all- K240455BD Vacutainer® Citrate Blood Collection TubesBecton, Dickinson and Company · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013971 | BD Vacutainer Safety Coagulation Tube | Becton, Dickinson & CO | 2002 | — |
| +1 | K240455 | BD Vacutainer® Citrate Blood Collection Tubes | Becton, Dickinson and Company | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (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 |
|---|---|---|---|
| * | — | VACUTAINER™ Brand Sodium Citrate 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 |
|---|---|---|---|
| K240455 | BD Vacutainer® Citrate Blood Collection Tubes | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 11, 2018 | Class II | Z-2258-2018 | Nonconforming Material/Component | Approximately 3.4% of BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (2.7mL) (light blue top tube) will exhibit over fill draw volumes from ~11-14%. |
| Apr 11, 2018 | Class II | Z-2260-2018 | Nonconforming Material/Component | Approximately 3.4% of BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (2.7mL) (light blue top tube) will exhibit over fill draw volumes from ~11-14%. |
| Apr 11, 2018 | Class II | Z-2259-2018 | Nonconforming Material/Component | Approximately 3.4% of BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (2.7mL) (light blue top tube) will exhibit over fill draw volumes from ~11-14%. |
| Jun 23, 2014 | Class II | Z-2633-2014 | Storage | Products were held at improper storage temperature |
| Nov 12, 2012 | Class II | Z-0756-2013 | Material/Component Contamination | BD is conducting a recall of the BD Vacutainer 2.7mL Plus Citrate Blood Collection Tube due to extended Partial Thromboplastin Time (aPTT) test results reported in two customer complaints. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K240455 (Becton, Dickinson and Company, 2024) 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™ Safety Coagulation tube is a plastic evacuated blood collection tube that provides a means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anticoagulated specimen that may be used for clinical laboratory coagulation assays. The benefits of a safety plastic coagulation tube with Hemogard Safety Closure Assembly are:
¢ reduced risk of specimen tube breakage
¢ reduced exposure to blood by laboratory personnel and to minimize blood splatter during stopper removal
These benefits lead to increased safety of laboratory personnel and reduced necessity of repeat specimen collection.
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/K013971 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013971: BD Vacutainer Safety Coagulation Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013971
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026