510(k) · Cleared
ClearedBD Vacutainer SST II Plus Tubes
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 Nov 25, 2002 as substantially equivalent to K960250 (Becton Dickinson Vacutainer Systems, 1996) after a 52-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Nov 25, 2002
- Review
- 52 days
- Class
- Class II
- Product code
- JKA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K960250 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK960250 Vacutainer Brand Plus Serum & SST TubesBecton Dickinson Vacutainer Systems · 1996 · Recalled
- This deviceK023331 BD Vacutainer SST II Plus TubesBecton, Dickinson & CO · 2002
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) | K023331 | BD Vacutainer SST II Plus Tubes | Becton, Dickinson & CO | 2002 | — |
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 |
|---|---|---|---|
| * | K960250 | Vacutainer Brand Plus Serum & SST TubesSummary page 3…inerTM Preamendment NA BD Vacutainer Systems PLUS SST Tube BD VacutainerTM K960250 3/29/96 F Jing Zhang Date Manager Regulatory A… | 1996 |
| * | — | BD Vacutainer Brand Serum Tube Named without a submission number |
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.
- 1 other device also cites its predicate K960250.
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 VacutainerTM SSTTMII PLUS Tube is a plastic evacuated blood collection tube with silica clot activator and gel barrier material that provides a means of collecting, transporting, separating, and processing blood in a closed tube. Blood collected in a BD VacutainerTM SSTTM II PLUS Tube is primarily used for clinical laboratory testing - chemistry assays using patient serum but may be used for other assays requiring serum specimens as determined by the laboratory. In addition, the BD VacutainerTM SSTTM11 PLUS Tube is compatible with many commonly used therapeutic drugs and is therefore suitable for therapeutic drug monitoring (TDM).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023331 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023331: BD Vacutainer SST II Plus Tubes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023331
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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