510(k) · Cleared
Recalled · Class II · 2018BD Vacutainer Plus SST Serum Separator Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd Vacutainer Systems Preanalyical Solutions · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Nov 25, 2002 as substantially equivalent to K960250 (Becton Dickinson Vacutainer Systems, 1996) after a 70-day review. Its family tree reaches back 1 generation to 1996. 3 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 25, 2002
- Review
- 70 days
- Class
- Class II
- Product code
- JKA
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K960250 (1996). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK960250 Vacutainer Brand Plus Serum & SST TubesBecton Dickinson Vacutainer Systems · 1996 · Recalled
- This deviceK023075 BD Vacutainer Plus SST Serum Separator TubeBd Vacutainer Systems Preanalyical Solutions · 2002
- Descendant · cites it directly · 0 of its ownK230855 BD Vacutainer® Serum Separator (SST™) Blood Collection TubesBecton, Dickinson and Company · 2023
- Descendant · cites it directly · 0 of its ownK093910 Improvacuter Gel & Clot Activator TubeGuangzhou Improve Medical Instruments Co., Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK060364 Vacu Lab Plain Tube, Vacu Lab Gel & Clot Activator Tube, Vacu Lab…Teco Diagnostics · 2006
Most influential descendants
Showing 3 of 3 · See all- K230855BD Vacutainer® Serum Separator (SST™) Blood Collection TubesBecton, Dickinson and Company · 2023 · cites it directly0descendants
- K093910Improvacuter Gel & Clot Activator TubeGuangzhou Improve Medical Instruments Co., Ltd. · 2010 · cites it directly0descendants
- K060364Vacu Lab Plain Tube, Vacu Lab Gel & Clot Activator Tube, Vacu Lab Coagulation TubeTeco Diagnostics · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960250 | Vacutainer Brand Plus Serum & SST Tubes | Becton Dickinson Vacutainer Systems | 1996 | 3 |
| 0 (this device) | K023075 | BD Vacutainer Plus SST Serum Separator Tube | Bd Vacutainer Systems Preanalyical Solutions | 2002 | — |
| +1 | K230855 | BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes | Becton, Dickinson and Company | 2023 | — |
| +1 | K093910 | Improvacuter Gel & Clot Activator Tube | Guangzhou Improve Medical Instruments Co., Ltd. | 2010 | — |
| +1 | K060364 | Vacu Lab Plain Tube, Vacu Lab Gel & Clot Activator Tube, Vacu Lab Coagulation… | Teco Diagnostics | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K960250 | Vacutainer Brand Plus Serum & SST TubesSummary page 3…: Predicate Device K-Number Clearance Date BD Vacutainer Systems, VacutainerTM K96025 0 March 29, 1996 Preanalytical Solutions PLUS SSTTM Serum Separator… | 1996 |
What descends from it? (3)
3 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 |
|---|---|---|---|---|
| Feb 13, 2018 | Class II | Z-2056-2018 | Nonconforming Material/Component | Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube |
| Feb 13, 2018 | Class II | Z-2055-2018 | Nonconforming Material/Component | Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube |
| 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?
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 Vacutainer PLUS SST Tube is a plastic evacuated blood collection tube with silica clot activator and gel that provides a means of collecting, transporting, separating, and processing blood in a closed tube. Blood collected in a Vacutainer PLUS SST Tube is primarily used for clinical laboratory testing in chemistry using patient serum, but may be used for other assays requiring serum specimens as determined by the laboratory. In addition, the…
Read the full statement (117 words)
The Vacutainer PLUS SST Tube is a plastic evacuated blood collection tube with silica clot activator and gel that provides a means of collecting, transporting, separating, and processing blood in a closed tube. Blood collected in a Vacutainer PLUS SST Tube is primarily used for clinical laboratory testing in chemistry using patient serum, but may be used for other assays requiring serum specimens as determined by the laboratory. In addition, the Vacutainer PLUS SST Tube is compatible with many commonly used therapeutic drugs therefore suitable for therapeutic drug monitoring (TDM). Blood can be collected, processed and stored in a Vacutainer PLUS SST tube for at least 24 hours for therapeutic drug monitoring without large losses in recovery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023075 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023075: BD Vacutainer Plus SST Serum Separator Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023075
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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