510(k) · Cleared
Recalled · Class II · 2019Vacutainer (R) Brand Plus PST (TM) Plasma Separation Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd Becton Dickinson Vacutainer Systems Preanalytic · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Jan 18, 1995 after a 43-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 18 later devices descend from it. It has been recalled 10 times.
- Decided
- Jan 18, 1995
- Review
- 43 days
- Class
- Class II
- Product code
- JKA
- Recalls
- 10
- Predicates
- 0
18 later devices descend from it, 3 citing it directly.
- This deviceK945952 Vacutainer (R) Brand Plus PST (TM) Plasma Separation TubeBd Becton Dickinson Vacutainer Systems Preanalytic · 1995
- Descendant · cites it directly · 13 of its ownK972075 Vacutainer Brand PPT Plasma Preparation TubeBecton Dickinson Vacutainer Systems · 1998
- Descendant · 2 generations on · 6 of its ownK110701 Oragene-DX Ogd-500; Oragene-DX Ogd-575; Oragene-DX Oxd-525…DNA Genotek, Inc. · 2011
- Descendant · 3 generations on · 3 of its ownK141410 Oragene DX Ogd-500.001DNA Genotek, Inc. · 2015
- Descendant · 3 generations on · 2 of its ownK152556 Oragene DxDNA Genotek, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK022130 BD Vacutainer Plus PST II TubeBecton, Dickinson & CO · 2002
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K972075Vacutainer Brand PPT Plasma Preparation TubeBecton Dickinson Vacutainer Systems · 1998 · cites it directly13descendants
- K110701Oragene-DX Ogd-500; Oragene-DX Ogd-575; Oragene-DX Oxd-525; Oragene-DX Oyd-500DNA Genotek, Inc. · 2011 · 2 generations on6descendants
- K141410Oragene DX Ogd-500.001DNA Genotek, Inc. · 2015 · 3 generations on3descendants
- K152556Oragene DxDNA Genotek, Inc. · 2016 · 3 generations on2descendants
- K022130BD Vacutainer Plus PST II TubeBecton, Dickinson & CO · 2002 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K945952 | Vacutainer (R) Brand Plus PST (TM) Plasma Separation Tube | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995 | — |
| +1 | K972075 | Vacutainer Brand PPT Plasma Preparation Tube | Becton Dickinson Vacutainer Systems | 1998 | — |
| +2 | K110701 | Oragene-DX Ogd-500; Oragene-DX Ogd-575; Oragene-DX Oxd-525; Oragene-DX Oyd-500 | DNA Genotek, Inc. | 2011 | — |
| +3 | K141410 | Oragene DX Ogd-500.001 | DNA Genotek, Inc. | 2015 | — |
| +3 | K152556 | Oragene Dx | DNA Genotek, Inc. | 2016 | — |
| +1 | K022130 | BD Vacutainer Plus PST II Tube | Becton, Dickinson & CO | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (18)
See all 183 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 12, 2019 | Class II | Z-2300-2019 | Device Design | False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument. |
| Jun 12, 2019 | Class II | Z-2304-2019 | Device Design | False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument. |
| Jun 12, 2019 | Class II | Z-2301-2019 | Device Design | False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument. |
| Jun 12, 2019 | Class II | Z-2305-2019 | Device Design | False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument. |
| Jun 12, 2019 | Class II | Z-2302-2019 | Device Design | False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument. |
| Jun 12, 2019 | Class II | Z-2303-2019 | Device Design | False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument. |
| Jun 12, 2019 | Class II | Z-2308-2019 | Device Design | False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument. |
| Mar 16, 2017 | Class II | Z-1746-2017 | Nonconforming Material/Component | BD is initiating this product correction of multiple lots of BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (13x75 mm x 4.5 mL). A limited number of tubes in these lots may exhibit stopper pullout from the tube as the… |
| Jan 16, 2017 | Class II | Z-1189-2017 | Process control | A portion of this lot of blood collection tubes was manufactured with approximately twice the expected amount of buffered sodium citrate additive, an anticoagulant. |
| Mar 5, 2012 | Class III | Z-0911-2013 | Equipment maintenance | BD is conducting a recall of the BD Vacutainer Plus Plastic Plasma Separator Tube (PST) with Light Green/BD Homogard Closure due to a deformed top of the tube reservoir reported in two customer complaints. |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K972075 (Becton Dickinson Vacutainer Systems, 1998) has gone furthest, with 13 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 | — |
https://510kreport.com/device/K945952 · printed Nov 4, 2026
Cite this page
510(k) Report. “K945952: Vacutainer (R) Brand Plus PST (TM) Plasma Separation Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K945952
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026