510(k) · Cleared
Recalled · Class II · 2014Vacutainer Brand Plus Serum & SST Tubes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton Dickinson Vacutainer Systems · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Mar 29, 1996 after a 73-day review. The FDA summary names its predicate without a number. 5 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 29, 1996
- Review
- 73 days
- Class
- Class II
- Product code
- JKA
- Recalls
- 3
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK960250 Vacutainer Brand Plus Serum & SST TubesBecton Dickinson Vacutainer Systems · 1996
- Descendant · cites it directly · 3 of its ownK023075 BD Vacutainer Plus SST Serum Separator TubeBd Vacutainer Systems Preanalyical Solutions · 2002 · Recalled
- Descendant · 2 generations on · 0 of its ownK230855 BD Vacutainer® Serum Separator (SST™) Blood Collection TubesBecton, Dickinson and Company · 2023
- Descendant · 2 generations on · 0 of its ownK093910 Improvacuter Gel & Clot Activator TubeGuangzhou Improve Medical Instruments Co., Ltd. · 2010
- Descendant · 2 generations on · 0 of its ownK060364 Vacu Lab Plain Tube, Vacu Lab Gel & Clot Activator Tube, Vacu Lab…Teco Diagnostics · 2006
- Descendant · cites it directly · 0 of its ownK023331 BD Vacutainer SST II Plus TubesBecton, Dickinson & CO · 2002
Most influential descendants
Showing 5 of 5 · See all- K023075BD Vacutainer Plus SST Serum Separator TubeBd Vacutainer Systems Preanalyical Solutions · 2002 · cites it directly3descendants
- K230855BD Vacutainer® Serum Separator (SST™) Blood Collection TubesBecton, Dickinson and Company · 2023 · 2 generations on0descendants
- K093910Improvacuter Gel & Clot Activator TubeGuangzhou Improve Medical Instruments Co., Ltd. · 2010 · 2 generations on0descendants
- K060364Vacu Lab Plain Tube, Vacu Lab Gel & Clot Activator Tube, Vacu Lab Coagulation TubeTeco Diagnostics · 2006 · 2 generations on0descendants
- K023331BD Vacutainer SST II Plus TubesBecton, Dickinson & CO · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960250 | Vacutainer Brand Plus Serum & SST Tubes | Becton Dickinson Vacutainer Systems | 1996 | — |
| +1 | K023075 | BD Vacutainer Plus SST Serum Separator Tube | Bd Vacutainer Systems Preanalyical Solutions | 2002 | 3 |
| +2 | K230855 | BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes | Becton, Dickinson and Company | 2023 | — |
| +2 | K093910 | Improvacuter Gel & Clot Activator Tube | Guangzhou Improve Medical Instruments Co., Ltd. | 2010 | — |
| +2 | K060364 | Vacu Lab Plain Tube, Vacu Lab Gel & Clot Activator Tube, Vacu Lab Coagulation… | Teco Diagnostics | 2006 | — |
| +1 | K023331 | BD Vacutainer SST II Plus Tubes | Becton, Dickinson & CO | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 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? (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 PLUS Serum and SST® Serum Separator Tubes (All Tube Volumes) Named without a submission number |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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-2629-2014 | Storage | Products were held at improper storage temperature |
| Jun 23, 2014 | Class II | Z-2631-2014 | Storage | Products were held at improper storage temperature |
| Aug 20, 2004 | Not classified | Z-0052-05 | Other | "Please be aware tht this not a new recall. The firm has taken action; but, due to administrative issues additional products are now being classified by the agency". There is an apparent bias in the determination of Total T3, Total T4… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K023075 (Bd Vacutainer Systems Preanalyical Solutions, 2002) has gone furthest, with 3 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?
An evacuated tube which provides a means of collecting, transporting, separating and processing venous blood in a closed system. Blood collected in these tubes is primarily used for clinical laboratory chemistry assays using patient serum but may be used for other serum specimens as determined by the laboratory.
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/K960250 · printed Nov 5, 2026
Cite this page
510(k) Report. “K960250: Vacutainer Brand Plus Serum & SST Tubes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K960250
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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