510(k) · Cleared
ClearedVacutainer Brand PPT Plasma Preparation Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton Dickinson Vacutainer Systems · PJE Blood/Plasma Collection Device For Dna Testing
Cleared on Feb 24, 1998 as substantially equivalent to K953463 (Becton Dickinson Vacutainer Systems, 1995) and 1 other predicate after a 266-day review. Its family tree reaches back 1 generation to 1995. 13 later devices descend from it.
- Decided
- Feb 24, 1998
- Review
- 266 days
- Class
- Class II
- Product code
- PJE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K945952 (1995). 2 ancestors in all. 13 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK945952 Vacutainer (R) Brand Plus PST (TM) Plasma Separation TubeBd Becton Dickinson Vacutainer Systems Preanalytic · 1995 · Recalled
- This deviceK972075 Vacutainer Brand PPT Plasma Preparation TubeBecton Dickinson Vacutainer Systems · 1998
- Descendant · cites it directly · 6 of its ownK110701 Oragene-DX Ogd-500; Oragene-DX Ogd-575; Oragene-DX Oxd-525…DNA Genotek, Inc. · 2011
- Descendant · 2 generations on · 3 of its ownK141410 Oragene DX Ogd-500.001DNA Genotek, Inc. · 2015
- Descendant · 2 generations on · 2 of its ownK152556 Oragene DxDNA Genotek, Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK192920 Oragene®•DxDNA Genotek, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK142821 PAXgene Blood DNA TubePreanalytix GmbH · 2015
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K110701Oragene-DX Ogd-500; Oragene-DX Ogd-575; Oragene-DX Oxd-525; Oragene-DX Oyd-500DNA Genotek, Inc. · 2011 · cites it directly6descendants
- K141410Oragene DX Ogd-500.001DNA Genotek, Inc. · 2015 · 2 generations on3descendants
- K152556Oragene DxDNA Genotek, Inc. · 2016 · 2 generations on2descendants
- K192920Oragene®•DxDNA Genotek, Inc. · 2020 · 2 generations on1descendant
- K142821PAXgene Blood DNA TubePreanalytix GmbH · 2015 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945952 | Vacutainer (R) Brand Plus PST (TM) Plasma Separation Tube | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995 | 10 |
| 0 (this device) | K972075 | Vacutainer Brand PPT Plasma Preparation Tube | Becton Dickinson Vacutainer Systems | 1998 | — |
| +1 | K110701 | Oragene-DX Ogd-500; Oragene-DX Ogd-575; Oragene-DX Oxd-525; Oragene-DX Oyd-500 | DNA Genotek, Inc. | 2011 | — |
| +2 | K141410 | Oragene DX Ogd-500.001 | DNA Genotek, Inc. | 2015 | — |
| +2 | K152556 | Oragene Dx | DNA Genotek, Inc. | 2016 | — |
| +2 | K192920 | Oragene®•Dx | DNA Genotek, Inc. | 2020 | — |
| +1 | K142821 | PAXgene Blood DNA Tube | Preanalytix GmbH | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 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 PJE? 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 PJE device
- #1 K231469 PAXgene® Blood DNA Tubescore 6.1 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K953463 | Vacutainer Plus Tubes | 1995 |
| * | K945952 | Vacutainer (R) Brand Plus PST (TM) Plasma Separation TubeSummary page 4…ce " | K-Number | Clearance Date VACUTAINER Systems VACUTAINER® Brand PLUS Tube with | K9853463 9/20/95 EDTA Anticoagulant VACUTAINER Systems VACUTAINER™ Brand PST™ Tube K945952 1/18/95 hn flf‘/ December 4, 1997 chalago Date egu a.tory Affairs Specialist Regulatory Affairs Department DEP… | 1995 |
What descends from it? (13)
See all 135 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K110701 (DNA Genotek, Inc., 2011) has gone furthest, with 6 descendants of its own.
How does its category compare?
All PJE devicesPJE Blood/Plasma Collection Device For Dna Testing: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · PJE
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · PJE
Too few PJE 510(k)s in any year since 2007 to give a median.
Recalls per year · PJE
No recall names PJE since 2007.
Adverse event reports per year · PJE
257in 2025
MAUDE reports naming product code PJE, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 27 |
| 2019 | 0 | — | 0 | 12 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 14 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 1 | — | 0 | 63 |
| 2024 | 0 | — | 0 | 168 |
| 2025 | 0 | — | 0 | 257 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The VACUTAINER® Brand PPT™ Plasma Preparation Tube with EDTA anticoagulant and a gel barrier material are evacuated blood collection tubes which provide a means of collecting, processing and transporting blood in a closed plastic tube. When the Tube is used together with VACUTAINER® Brand needles and holders, it is a closed system for the collection of venous blood with the same indications identified here. Blood collected in a tube containing EDTA…
Read the full statement (123 words)
The VACUTAINER® Brand PPT™ Plasma Preparation Tube with EDTA anticoagulant and a gel barrier material are evacuated blood collection tubes which provide a means of collecting, processing and transporting blood in a closed plastic tube. When the Tube is used together with VACUTAINER® Brand needles and holders, it is a closed system for the collection of venous blood with the same indications identified here.
Blood collected in a tube containing EDTA anticoagulant and gel barrier material can be primarily used to provide undiluted plasma for use in molecular diagnostic test methods; including but not limited to Polymerase Chain Reaction (PCR) and branched-DNA (bDNA). The specimen may also be used for other testing that requires an undiluted plasma sample 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/K972075 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972075: Vacutainer Brand PPT Plasma Preparation Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972075
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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