510(k) · Cleared
Recalled · 2004Microtainer Brand Tube with Edta (K2)
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 Aug 2, 1994 after a 159-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 2, 1994
- Review
- 159 days
- Class
- Class II
- Product code
- JKA
- Recalls
- 2
- Predicates
- 0
6 later devices descend from it, 4 citing it directly.
- This deviceK940905 Microtainer Brand Tube with Edta (K2)Bd Becton Dickinson Vacutainer Systems Preanalytic · 1994
- Descendant · cites it directly · 2 of its ownK093972 BD Microtainer Map Microtube for Automated Process, Model 363706Becton, Dickinson & CO · 2010 · Recalled
- Descendant · 2 generations on · 0 of its ownK230493 BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H…Becton, Dickinson and Company · 2023
- Descendant · 2 generations on · 0 of its ownK182078 MiniCollect K2E K2EDTA TubesGreiner Bio-One Na, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK063357 Minicollect Capillary Blood Collection TubesGreiner Bio-One North America, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK982999 Greiner Minicollect Edta Blood Collection TubeGreiner Meditech, Inc. · 1998
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K093972BD Microtainer Map Microtube for Automated Process, Model 363706Becton, Dickinson & CO · 2010 · cites it directly2descendants
- K230493BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood…Becton, Dickinson and Company · 2023 · 2 generations on0descendants
- K182078MiniCollect K2E K2EDTA TubesGreiner Bio-One Na, Inc. · 2019 · 2 generations on0descendants
- K063357Minicollect Capillary Blood Collection TubesGreiner Bio-One North America, Inc. · 2007 · cites it directly0descendants
- K982999Greiner Minicollect Edta Blood Collection TubeGreiner Meditech, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940905 | Microtainer Brand Tube with Edta (K2) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994 | — |
| +1 | K093972 | BD Microtainer Map Microtube for Automated Process, Model 363706 | Becton, Dickinson & CO | 2010 | 1 |
| +2 | K230493 | BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary… | Becton, Dickinson and Company | 2023 | — |
| +2 | K182078 | MiniCollect K2E K2EDTA Tubes | Greiner Bio-One Na, Inc. | 2019 | — |
| +1 | K063357 | Minicollect Capillary Blood Collection Tubes | Greiner Bio-One North America, Inc. | 2007 | — |
| +1 | K982999 | Greiner Minicollect Edta Blood Collection Tube | Greiner Meditech, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 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? (6)
4 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 |
|---|---|---|---|---|
| Aug 20, 2004 | Not classified | Z-1603-05 | Other | "Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-0052-05). The firm has taken action; but, due to administrative issues additional products are now being classified by the agency". There is… |
| Oct 16, 2002 | Not classified | Z-0447-03 | Other | Insufficient amount of EDTA found within the tube causing clotting and erroneous platelet counts. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K093972 (Becton, Dickinson & CO, 2010) has gone furthest, with 2 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/K940905 · printed Nov 4, 2026
Cite this page
510(k) Report. “K940905: Microtainer Brand Tube with Edta (K2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K940905
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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