510(k) · Cleared
ClearedVacuette Edta K2 Gel 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 Sep 24, 2001 as substantially equivalent to K972075 (Becton Dickinson Vacutainer Systems, 1998) after an 87-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Sep 24, 2001
- Review
- 87 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. No later device cites it as a predicate yet.
- 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 deviceK012043 Vacuette Edta K2 Gel TubesGreiner Vacuette North America, Inc. · 2001
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) | K012043 | Vacuette Edta K2 Gel Tubes | Greiner Vacuette North America, Inc. | 2001 | — |
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 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 TubeSummary page 1…stem Classification Name: Tubes, Vials, Systems, Serum Separators, Blood Collection PREDICATE DEVICE: Becton Dickinson Vacutainer® Brand PPT™ Plasma Preparation Tube (K972075) DEVICE DESCRIPTION: INTENDED USE: The VACUETTE® EDTA K2 Gel tube provides a means for collection, processing and transportatio… | 1998 |
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?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 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 Gel 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, and a gel barrier material. The VACUETTE® EDTA K2 Gel tube is used for plasma preparation and is made of plastic for the collection of venous blood which upon…
Read the full statement (113 words)
The VACUETTE® EDTA K2 Gel 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, and a gel barrier material. The VACUETTE® EDTA K2 Gel 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/K012043 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012043: Vacuette Edta K2 Gel Tubes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012043
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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