510(k) · Cleared
ClearedBD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection 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 Mar 13, 2026 as substantially equivalent to K945952 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1995) and 1 other predicate after a 256-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Mar 13, 2026
- Review
- 256 days
- Class
- Class II
- Product code
- JKA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K944566 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK944566 Vacutainer Brand Plus Sodium Heparin TubeBd Becton Dickinson Vacutainer Systems Preanalytic · 1994 · Recalled
- This deviceK252040 BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium…Becton, Dickinson and Company · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944566 | Vacutainer Brand Plus Sodium Heparin Tube | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994 | 2 |
| 0 (this device) | K252040 | BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin… | Becton, Dickinson and Company | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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? (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 |
|---|---|---|---|
| * | K945952 | Vacutainer (R) Brand Plus PST (TM) Plasma Separation TubeSummary page 7…ification Regulation: 21 CFR § 862.1675 Regulatory Class: Class II Product Code: JKA, GIM 1.9 Predicate Device BD Vacutainer® Brand PLUS PST™ Plasma Separator Tube (K945952) BD Vacutainer® Brand Plus Sodium Heparin Tube (K944566) 1.10 Device Establishment Becton, Dickinson and Company 1.11 Reg… | 1995 |
| * | K944566 | Vacutainer Brand Plus Sodium Heparin TubeSummary page 7…Class II Product Code: JKA, GIM 1.9 Predicate Device BD Vacutainer® Brand PLUS PST™ Plasma Separator Tube (K945952) BD Vacutainer® Brand Plus Sodium Heparin Tube (K944566) 1.10 Device Establishment Becton, Dickinson and Company 1.11 Registration Number: 2243072 1.12 Performance Standards:… | 1994 |
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?
- 2 of the 2 ancestors have a recall of any class.
- 2 other devices also cite its predicate K945952.
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. 2026, 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?
The BD Vacutainer® Plasma Separator Tubes (PST™) are evacuated, sterile, single-use, in vitro diagnostic medical devices. They are intended to be used by healthcare professionals for the collection, containment, and transport of human venous blood specimens, and the subsequent separation and storage of plasma for in vitro diagnostic testing. BD Vacutainer® Plasma Separator Tubes (PST™) are used for testing chemistry analytes in plasma samples. The BD…
Read the full statement (133 words)
The BD Vacutainer® Plasma Separator Tubes (PST™) are evacuated, sterile, single-use, in vitro diagnostic medical devices. They are intended to be used by healthcare professionals for the collection, containment, and transport of human venous blood specimens, and the subsequent separation and storage of plasma for in vitro diagnostic testing.
BD Vacutainer® Plasma Separator Tubes (PST™) are used for testing chemistry analytes in plasma samples.
The BD Vacutainer® Sodium Heparin Blood Collection Tube is a sterile, single-use, in vitro diagnostic medical device for the collection, containment, transport of human venous blood specimens, and the subsequent separation of plasma by centrifugation, for in vitro diagnostic testing. It is used in settings where a venous blood specimen is collected by a healthcare professional.
The BD Vacutainer® Sodium Heparin Blood Collection Tube is used for testing lithium.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252040 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252040: BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252040
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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