510(k) · Cleared
ClearedVacuette Edta K2 Tubes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Greiner Vacuette North America, Inc. · PJE Blood/Plasma Collection Device For Dna Testing
Cleared on Feb 1, 2002 as substantially equivalent to K972075 (Becton Dickinson Vacutainer Systems, 1998) after a 50-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.
- Decided
- Feb 1, 2002
- Review
- 50 days
- Class
- Class II
- Product code
- PJE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K945952 (1995). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK945952 Vacutainer (R) Brand Plus PST (TM) Plasma Separation TubeBd Becton Dickinson Vacutainer Systems Preanalytic · 1995 · Recalled
- 1 generation backK972075 Vacutainer Brand PPT Plasma Preparation TubeBecton Dickinson Vacutainer Systems · 1998
- This deviceK014104 Vacuette Edta K2 TubesGreiner Vacuette North America, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK063357 Minicollect Capillary Blood Collection TubesGreiner Bio-One North America, Inc. · 2007
Most influential descendants
Showing 1 of 1 · See all- K063357Minicollect Capillary Blood Collection TubesGreiner Bio-One North America, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945952 | Vacutainer (R) Brand Plus PST (TM) Plasma Separation Tube | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995 | 10 |
| −1 | K972075 | Vacutainer Brand PPT Plasma Preparation Tube | Becton Dickinson Vacutainer Systems | 1998 | — |
| 0 (this device) | K014104 | Vacuette Edta K2 Tubes | Greiner Vacuette North America, Inc. | 2002 | — |
| +1 | K063357 | Minicollect Capillary Blood Collection Tubes | Greiner Bio-One North America, Inc. | 2007 | — |
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 |
|---|---|---|
| 2007 | 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? (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 |
|---|---|---|---|
| * | K972075 | Vacutainer Brand PPT Plasma Preparation Tube Our OCR of the scanned summary read K572075, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Becton Dickinson Vacutainer® Brand PPT™ Plasma Preparation Tube”. | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063357 | Minicollect Capillary Blood Collection Tubes | 2007 | 0 |
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?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K063357 (Greiner Bio-One North America, Inc., 2007) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K972075.
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 VACUETTE® EDTA K2 tube provides a means for collection, processing and transportation of an undiluted plasma specimen in a closed evacuated system. The tube contains spray-dried EDTA, yielding a ratio of 1.8mg/mL of blood when the evacuated tube is filled correctly to its fill volume. The VACUETTE® EDTA K2 tube is used for plasma preparation and is made of plastic for the collection of venous blood which upon centrifugation separates undiluted plasma for use in molecular diagnostic test methods (such as but not limited to PCR — Polymerase Chain Reaction), or other procedures where an undiluted plasma specimen is required 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/K014104 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014104: Vacuette Edta K2 Tubes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014104
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026